Senior Quality Specialist

Cost Accountant

Safety, Health & Environment Manager

Technical Support Specialist

EHS Manager

Site Investigation Lead, Quality Assurance

HR Transaction Delivery Analyst

Consulting Principal AWS Cloud Engineer

Operations Supervisor

Quality Control Supervisor

Responsibilities: <ul><li>Point of Contact for all quality matters, enquiries, and support to both internal and external customers</li><li>Develop, implement and align quality strategies to ensure processes and procedures meet quality excellence standards</li><li>Lead and mentor colleagues at sales operations offices, fostering a culture of excellence and accountability</li><li>Oversee the management of ISO 9001:2015 and quality system (CAPA, Change Management, Investigation, etc.)&nbsp;</li><li>Manage, own and investigate product complaints</li><li>Business Process Owner for Document Control</li><li>Analyse and track quality metrics such as Complaint KPI</li><li>Conduct/Host audits (internal and external) and inspections to ensure compliance with regulatory, quality and internal standards</li><li>Manage and negotiate quality agreements with end customers, group legal and global quality&nbsp;</li><li>Support quality documentation requests from customers</li><li>Ensure documentation and traceability of quality processes and corrective actions</li><li>Facilitate quality management reviews and relevant quality meetings</li><li>Manage supplier quality and conduct vendor assessments when necessary</li><li>Collaborate with cross-functional teams (e.g., global supply, sales, global quality, support teams) to resolve quality issues</li><li>Stay updated on industry trends, standards, and regulatory changes (where required)</li><li>Drive continuous improvement initiatives using Lean, Six Sigma, or other methodologies</li></ul> Requirements:﻿ <ul><li>Bachelor’s degree in Biological Sciences, Quality Engineering, or related fields</li><li>5+ years of experience in quality assurance, quality compliance, supplier quality or quality operations&nbsp;</li><li>Strong knowledge of QA methodologies, tools, and standards (e.g., ISO 9001:2015, ISO 13485, cGMP/GxP relevant)</li><li>Auditor certification in quality standards preferred</li><li>Strong knowledge in investigation and RCA methodology, and technical writing skills</li><li>Proficiency in quality management systems softwares (e.g., Trackwise)</li><li>Excellent analytical, problem-solving, and decision-making skills</li><li>Strong communication and interpersonal skills</li><li>Able to work in fast-paced, dynamic environments</li><li>Detail-oriented with a strategic mindset</li><li>Independent, Proactive and Task-driven</li><li>Leadership experience preferred</li></ul>

Responsibilities: <ul><li>Lead the plant’s cost accounting function, including design and implementation of robust cost control systems.</li><li>Develop and manage detailed product costing, activity-based costing models, and process-wise profitability analysis.</li><li>Provide deep insights on cost trends, production efficiency, and inventory usage to support strategic decision-making.</li><li>Analyze standard vs actual costs and proactively address variances through root cause investigation and corrective actions.</li><li>Conduct plant-wide cost audits and coordinate with production, procurement, and supply chain teams for financial alignment.</li><li>Drive initiatives in waste reduction, process improvement, and cost optimization at both micro and macro levels.</li><li>Oversee inventory valuation, stock audits, and reconciliation of raw materials, WIP, and finished goods.</li><li>Collaborate with the Finance Head and Plant Director for capital expenditure planning and cost-benefit analysis.</li><li>Ensure compliance with Cost Accounting Standards, internal controls, and regulatory reporting requirements.</li><li>Prepare high-level MIS reports, dashboards, and executive summaries for senior management and board-level reviews.</li></ul> Requirements:﻿﻿<ul><li>CMA (Cost &amp; Management Accountant) qualified; additional MBA in Finance or CA Inter is an advantage.</li><li>8-10 years of progressive experience in cost accounting, with at least 3 years in a senior role in a manufacturing plant.</li><li>Proven track record in implementing cost optimization strategies and improving profitability.</li><li>Strong command of ERP systems (e.g., SAP, Oracle) and advanced Excel/Power BI for analytics.</li><li>In-depth understanding of cost structures, production processes, and inventory management in industrial environments.</li><li>Excellent communication, leadership, and cross-functional collaboration skills.</li></ul>

Responsibilities: Site Safety Management:&nbsp; <ul><li>Lead daily site-based safety activities, including risk assessments, toolbox talks, and audits.</li></ul> Regulatory Compliance:&nbsp; <ul><li>Ensure full compliance with Taiwan’s construction safety regulations and relevant international standards.</li></ul> Incident Response:&nbsp; <ul><li>Manage incident investigations, corrective actions, and reporting procedures.</li></ul> Contractor Oversight:&nbsp; <ul><li>Monitor and enforce safety standards for contractors and subcontractors on-site.</li></ul> Documentation &amp; Audits:&nbsp; <ul><li>Maintain accurate SH&amp;E records and support both internal and external audits.</li></ul> Project Exposure: <ul><li>Operate across high-rise, industrial, commercial, or infrastructure construction environments.</li></ul> ﻿Requirements: <ul><li>Experience: 7+ years in construction or engineering environments, with hands-on SH&amp;E responsibilities; experience supporting both office-based and site-based operations.</li><li>Skills: Proficient in risk assessments, incident investigation, subcontractor safety oversight, SH&amp;E training delivery, and internal/external audit preparation.</li><li>Certifications: NEBOSH, ISO 45001 Internal Auditor, or Taiwan OSH license preferred.</li><li>Knowledge: In-depth understanding of Taiwan construction safety laws and international SH&amp;E standards; experience in aligning local operations with regional programs.</li><li>Language: Bilingual in Mandarin and English to effectively operate in multinational environments and communicate with local and regional stakeholders.</li><li>Location: Based in Taipei or willing to relocate; must be able to support project sites across Taiwan (only local Taiwanese can be considered)&nbsp;</li></ul>

Brookfield Culture
Brookfield has a unique and dynamic culture.  We seek team members who have a long-term focus and whose values align with our Attributes of a Brookfield Leader:  Entrepreneurial, Collaborative and Disciplined.  Brookfield is committed to the development of our people through challenging work assignments and exposure to diverse businesses.
Job Description 
Technology Services (TS) is responsible for delivering all enterprise infrastructure, applications and related end user technology services across all Brookfield business groups, comprised of approximately 6,500 users. The Deskside Technician is the face of Technology Services, providing first-line support to end users. 
The Technical Support Specialist will report to the Team lead, Deskside.  In addition to incident logging, resolution, and ownership, the Deskside Technician will collaborate with team members and other Technology Services teams to maintain and improve the end user experience of all Brookfield users. 
The ideal candidate for this role will possess the following attributes.
•	Accountability – candidate has a sense of ownership when troubleshooting a problem and will see things through to completion.
•	Professionalism - candidate maintains composure and integrity while providing timely support to end users.  
•	Detail Oriented – candidate takes the time to listen and understand the issue and works with the appropriate teams to resolve. 

Responsibilities:
•	Provides exceptional deskside and remote support to Brookfield users.
•	Owns and follows up on IT support requests and problem tickets until user confirms resolution. 
•	Provides installation, configuration, maintenance and troubleshooting support of computer hardware, software, audio/visual, networks, printers, and computer peripherals.
•	Provides technical training to end users. 
•	Ensures past incidents and resolutions are documented appropriately according to knowledge management standards. 
•	Positively represents Brookfield Technology Services with professionalism in all interactions. 
•	Proactively follows up on IT service requests/IT problem tickets until customer confirms resolution.
•	Collaborates with other team members to provide efficient, full-service support. 
•	Participates in testing new desktop technologies and software. 
•	Technician must maintain professionalism, good attitude and appropriate behavior with all users and vendors.
•	Technician will provide customer technical education, and support high level technical problems.
•	Assists, encourages, and serves as a backup to other team members.
Technical Skills
Knowledge of the following:
•	ITIL Methodology
•	Proficient with the following technologies: 
o	Windows 10 & 11, 
o	Microsoft Office (O365)
o	Internet Browsers, 
o	Local Account Management, 
o	Installs and removals, Registry, Command line, Service management systems and System Management Tools,
o	MFA (Microsoft Authentication)
o	VPNs
•	Proficient with the following hardware:
o	Desktop / Laptop
o	iPad/iPhone, 
o	Android Phones/Devices 
o	Printers
o	Cisco Video Conferencing equipment, 
o	Teams phones
•	Knowledge of wide area networks (SDWAN), TCP/IP, and Server OS is desired.
Experience
•	5+ years of related experience
•	Bachelor’s degree in computer science, business computing, or a related field, or equivalent combination of education, certification, and experience.
•	Preferred experience with financial services, with front office support a plus
•	Experience in a related role requiring, timeliness, customer service, organization, prioritization, troubleshooting, and working independently to successfully install, configure, maintain, and support Windows and/or Mac desktop operating systems and software.
•	Strong and effective customer relationship management skills and process/practice experience
•	Experience working with third-party service provider service delivery execution and business governance.
•	Experience with ServiceNow ticketing system preferred, but not required.
•	Understands the importance and is vigilant with Cybersecurity matters.



Responsibilities:
•	Provides exceptional deskside and remote support to Brookfield users.
•	Owns and follows up on IT support requests and problem tickets until user confirms resolution. 
•	Provides installation, configuration, maintenance and troubleshooting support of computer hardware, software, audio/visual, networks, printers, and computer peripherals.
•	Provides technical training to end users. 
•	Ensures past incidents and resolutions are documented appropriately according to knowledge management standards. 
•	Positively represents Brookfield Technology Services with professionalism in all interactions. 
•	Proactively follows up on IT service requests/IT problem tickets until customer confirms resolution.
•	Collaborates with other team members to provide efficient, full-service support. 
•	Participates in testing new desktop technologies and software. 
•	Technician must maintain professionalism, good attitude and appropriate behavior with all users and vendors.
•	Technician will provide customer technical education, and support high level technical problems.
•	Assists, encourages, and serves as a backup to other team members.


Responsibilities: <ul><li>Lead all EHS&amp;S initiatives at the Medway site.</li><li>Build and maintain a strong safety culture across departments.</li><li>Ensure compliance with federal, state, and local regulations including OSHA, EPA (CAA, CWA, RCRA, TSCA, SARA), and internal our client standard.</li><li>Develop and implement EHS programs, training, and internal audits.</li><li>Manage environmental permits, licenses, and waste disposal practices.</li><li>Coordinate emergency preparedness and hazardous material controls.</li><li>Lead incident investigations and root cause analysis.</li><li>Maintain ISO 14001 certification and drive continuous improvement.</li><li>Prepare EHS reports and metrics for internal and external stakeholders.</li><li>Represent the site during audits by customers and regulatory agencies.</li><li>Oversee EHS budget and manage third-party consultants or vendors as needed.</li></ul> Requirements: Qualifications &amp; Experience&nbsp; <ul><li>Bachelor’s degree in Environmental, Health &amp; Safety or related field (required).</li><li>7+ years of EHS experience in a manufacturing environment.</li><li>Experience in medical devices or other highly regulated industries preferred.</li><li>CSP (Certified Safety Professional) certification preferred.</li><li>Experience with ISO 14001 implementation.</li><li>In-depth knowledge of hazardous waste, air/water compliance, chemical management, and emergency response protocols.</li></ul>

Responsibilities: Investigation Management <ul><li>Timely review and support to closing of OOS/OOT/Deviations/Market complaints/Customer notifications as an investigational SME Role.</li><li>Review and ensure identified Root cause/Hypothesis is based on sound scientific Rationale and evidence.</li><li>Review and ensure Investigation order is proper and logical.</li><li>Review and ensure Investigation articulation is proper and not Misleading /Ambiguous.</li><li>Review and ensure Identification of CAPA’s is consistent with investigation findings</li><li>Provide appropriate rating to Root cause investigation based on Hypothesis, Investigation order, Investigation articulation and Identification of CAPA’s.</li><li>Undertake continuous trainings and developments from an outcome of Investigations and CAPA’s.</li><li>Implementation of best practices in Investigation review mechanism, policies, processes and procedures to aid and improve operational performance and Quality Metrics.</li><li>Support to Implement all relevant procedures described in the Quality Management System (QMS) like Deviation, RCI, Complaint management etc.,</li><li>Develop and maintain strong relationships with internal and external stakeholders to ensure optimal performance.</li><li>Work collaboratively, negotiate and engage with key stakeholders to facilitate delivery and compliance with the quality strategy.</li><li>Review and identify areas of improvement in the investigations.</li><li>Ensure the compliance with current industrial practices and constantly meet the regulatory requirement with zero integrity issue.</li></ul> Workload Management&nbsp; <ul><li>Coordinate workload sharing with Investigators team and develop action plans to improve timeline and quality of investigations</li><li>Prepare monthly report of the issues, work done, any employee related issues and conduct bi-weekly audits of the analyst’s notebooks.</li></ul> Staff Development	 <ul><li>Evaluate potential candidates for Investigation team, performance evaluation of direct reports.</li></ul> Requirements: Education &amp; Experience&nbsp; <ul><li>Bachelor’s degree in pharmacy, Chemistry, Biotechnology, or related scientific discipline (master’s preferred)</li><li>10+ years of experience in pharmaceutical manufacturing, quality, or compliance roles, including investigation management</li><li>Prior experience leading teams and conducting root cause analysis for deviations, OOS/OOT, and quality events</li><li>Working knowledge of FDA, EU, and other global regulatory requirements Demonstrated management and leadership experience with strong interpersonal and influencing skills.</li></ul> Knowledge <ul><li>Proficiency in a body of information required for the job e.g. knowledge of FDA regulations, GMP/GLP/GCP, Lean Manufacturing, Six-Sigma, etc.</li><li>In-depth understanding of cGMP regulations, 21 CFR Part 211, ICH Q9/Q10 principles</li><li>Strong knowledge of manufacturing and QC processes for solid oral dosage forms, non-sterile liquids and semi-solid dosage forms</li><li>Familiarity with investigation tools and techniques (e.g., 5 Whys, Fishbone, FMEA)</li><li>Experience with Quality Management Systems (e.g., TrackWise, MasterControl)</li><li>Skills &amp; Abilities Often referred to as “competencies”, leadership attributes, skills, abilities or behaviors that may be enterprise, functional or job specific e.g. coaching, negotiation, calibration, technical writing etc.</li><li>Organizational Support - Follows policies and procedures; completes administrative tasks correctly and on time; supports organizations goals and values; benefits organization through outside activities; supports affirmative action and respects diversity.</li><li>Leadership - Exhibits confidence in self and others; inspires and motivates others to perform well; effectively influences actions and opinions of others; accepts feedback from others; gives appropriate recognition to others.</li><li>Supervising People - Includes staff in planning, decision-making, facilitating and process improvement; takes responsibility for subordinates activities; is available to staff; provides regular performance feedback; develops subordinates skills and encourages growth; solicits and applies customer feedback (internal and external); fosters quality focus in others; improves processes, products and services.; continually works to improve supervisory skills.</li><li>Quality - Demonstrates accuracy and thoroughness; looks for ways to improve and promote quality; applies feedback to improve performance; monitors own work to ensure quality.</li><li>Demonstrated flexibility in carrying out varied assignments in a high-quality work environment.</li><li>Excellent written and oral communications skills with a strong emphasis on organizational capabilities.</li><li>Excellent analytical thinking and problem-solving skills</li><li>Excellent critical thinking and root cause analysis skills</li><li>Ability to work cross-functionally and influence without authority</li><li>Proven ability to meet deadlines while handling multiple investigations</li></ul> Physical Requirements <ul><li>Physical &amp; mental requirements e.g. lift 40 pounds, walk across plant/warehouse, business travel (% of time), driving as part of work responsibilities, etc.</li><li>Ability to work on-site full-time in both office and GMP environments</li><li>Sit or stand for extended periods; walk between manufacturing and laboratory areas</li><li>Ability to occasionally lift or move materials up to 25 pounds</li><li>Use of personal protective equipment (PPE) as required Investigation Management</li></ul>

Responsibilities: <ul><li>Assist in processing financial transactions, ensuring accuracy, timeliness, and compliance with company policies and regulations.</li><li>Analyze transactional data to identify trends, discrepancies, and opportunities for process improvement.</li><li>Identify process gaps and recommend enhancements for improved efficiency.</li><li>Conduct quality checks and audits to verify data accuracy.</li><li>Track transaction case volume and workload in coordination with the team lead.</li><li>Assist the Transaction Delivery Manager in monitoring and reporting on performance metrics and service level agreements (SLAs).</li><li>Collaborate with team members to resolve transactional issues and respond to stakeholder queries.</li><li>Contribute to developing and implementing policies and procedures to standardize transactional processes.</li><li>Participate in continuous improvement initiatives, suggesting enhancements to systems and workflows.</li><li>Assist in preparing financial reports and documentation for audits.</li><li>Maintain knowledge of relevant financial regulations, accounting standards, and best practices.</li><li>Support the transition of transactional services to the shared services center, including data migration and system integration.</li><li>Serve as a secondary contact for HR Business Partners (HRBBPs), Centers of Excellence (COEs), and escalations as needed.</li><li>Ensure timely resolution of complaints to meet compliance requirements.</li><li>Provide training and support to new team members and end-users of transactional systems.</li><li>Collaborate with IT and other departments to optimize transactional systems in alignment with business needs.</li></ul>&nbsp;Requirements: Qualifications and Experience Essential: <ul><li>Bachelor’s degree in Accounting, Finance, Business Administration, or a related field.</li><li>Minimum of 2 years’ experience in a transactional services or financial analysis role.</li><li>Strong analytical and data analysis skills.</li><li>Proficiency in Microsoft Excel and other data analysis tools.</li><li>Experience with Workday and ServiceNow platforms.</li><li>Familiarity with financial processes and systems, including ERP and HRIS software.</li><li>High attention to detail with a strong commitment to accuracy and quality.</li><li>Effective communication and interpersonal skills; ability to work well in a team.</li><li>Strong multitasking and prioritization abilities in a fast-paced environment.</li><li>Knowledge of financial regulations and relevant accounting standards.</li></ul> Preferred: <ul><li>Experience with process improvement methodologies and a proactive mindset toward change.</li><li>Ability to quickly adapt to new systems, technologies, and processes.</li></ul> Technical and Functional Skills Preferred: <ul><li>Proficiency in Microsoft Office Suite.</li><li>Experience with Workday HCM modules (Core HR, Talent Management, Recruiting, Payroll).</li><li>Familiarity with ServiceNow modules (HR Service Delivery, Incident Management, Knowledge Management).</li><li>Advanced Microsoft Excel skills (e.g., pivot tables, VLOOKUP, advanced functions).</li><li>Knowledge of ERP systems for business process automation.</li><li>Understanding of financial regulations and compliance requirements related to transactional services.</li></ul> Languages <ul><li>Cluj, Romania:</li><li>Fluency in English</li><li>Proficiency in at least one additional language (French, Italian, Spanish, Romanian, or Czech)</li><li>Manila, Philippines:</li><li>Fluency in English</li><li>Proficiency in at least one additional language (Thai, Mandarin, or Spanish)</li><li>TBD, Mexico:</li><li>Fluency in English and Spanish</li></ul>

Responsibilities: <ul><li>Demonstrated ability to drive cultural change and advocate for cloud transformation Key Responsibilities Cloud Strategy &amp; Leadership&nbsp;</li><li>Develop and implement a comprehensive AWS cloud strategy, ensuring alignment with business and technology goals.&nbsp;</li><li>Provide technical leadership and advocacy, championing cloud-native best practices and innovation.&nbsp;</li><li>Lead and drive architectural decisions, ensuring scalability, security, and operational efficiency.</li><li>Cloud Architecture &amp; Design&nbsp;</li><li>Architect secure, scalable, and highly available AWS cloud environments.&nbsp;</li><li>Develop and maintain enterprise-wide cloud blueprints, patterns, and frameworks to drive consistency.&nbsp;</li><li>Research and integrate emerging cloud technologies to foster continuous innovation. Infrastructure as Code &amp; Automation&nbsp;</li><li>Lead adoption and implementation of Infrastructure as Code (IaC) using Terraform, AWS CloudFormation, and Helm.&nbsp;</li><li>Design and optimize CI/CD pipelines to streamline cloud deployments and operations.&nbsp;</li><li>Implement self-healing and automated failover mechanisms to enhance resilience and reliability.</li><li>Kubernetes &amp; Cloud-Native Technologies&nbsp;</li><li>Manage and optimize Kubernetes clusters (EKS, Helm, IAM) for scalability and security.&nbsp;</li><li>Define and enforce best practices for containerized applications and orchestration.&nbsp;</li><li>Improve Kubernetes networking, ingress, and observability solutions to enhance performance. Security &amp; Compliance&nbsp;</li><li>Establish and enforce security best practices for AWS environments, including IAM, WAF, Secret Manager, and encryption.&nbsp;</li><li>Implement zero-trust security models and secure multi-account AWS environments.&nbsp;</li><li>Conduct security audits, incident response, and ensure compliance with industry standards. Monitoring, Logging &amp; Reliability Engineering.</li><li>Deploy and manage monitoring tools (DataDog, Splunk, CloudWatch, Coralogix) to ensure visibility and observability.&nbsp;</li><li>Implement SRE principles to enhance system uptime, reliability, and efficiency.&nbsp;</li><li>Conduct post-mortem analysis and drive continuous improvements in cloud performance. Collaboration &amp; Thought Leadership&nbsp;</li><li>Work closely with software developers, system engineers, and security teams to design and implement cloud solutions.&nbsp;</li><li>Provide mentorship, training, and technical leadership to engineering teams.&nbsp;</li></ul> Requirements: <ul><li>10+ years of experience in IT, with at least 5+ years in AWS cloud engineering and architecture.</li><li>Deep understanding of AWS services, including EC2, EKS, RDS, S3, Lambda, VPC, IAM, Transit Gateway, and CloudFormation.&nbsp;</li><li>Expertise in Kubernetes (EKS, Helm, Daemon Sets, StatefulSets, Karpenter, external-dns, aws-cni).&nbsp;</li><li>Strong experience with Terraform, CloudFormation, and automation scripting (Bash, Python, PowerShell).&nbsp;</li><li>Hands-on experience managing CI/CD pipelines (Jenkins, GitHub Actions, Azure DevOps).&nbsp;</li><li>Proficiency in monitoring and logging tools (DataDog, Splunk, Coralogix, CloudWatch).&nbsp;</li><li>Strong networking and security knowledge (DNS, VPC, NAT, Security Groups, IAM).&nbsp;</li><li>Experience designing and developing scalable, production-grade software tools and automation scripts using Python. Preferred Certifications&nbsp;</li><li>AWS Certified Solutions Architect – Professional (or equivalent).&nbsp;</li><li>Additional certifications in Kubernetes (CKA), AWS Security, or DevOps are a plus. Leadership &amp; Soft Skills&nbsp;</li><li>Proven experience leading cloud architecture and strategy initiatives.&nbsp;</li><li>Ability to mentor and guide technical teams in a fast-paced, agile environment.&nbsp;</li><li>Strong problem-solving and troubleshooting skills in complex cloud environments.</li><li>Excellent communication skills with the ability to translate technical concepts for engineering, business, and executive stakeholders.&nbsp;</li></ul>

Role Description: <ul><li>Job Summary The Operations Supervisor is responsible for overseeing solid dosage pharmaceutical manufacturing and packaging activities during 2nd shift operations, 3:15pm to 11:45pm.&nbsp;</li><li>This role ensures that all production operations comply with cGMP, safety standards, and production schedules.</li><li>The operations supervisor will lead and support a team of leads and operators ensuring high quality output, operational efficiency, and a safe working environment.</li><li>Scope of Authority - span of control (work unit, site, department, division, etc.), monetary value of budget/spend authority ( capital, operating, etc.), P&amp;L responsibility, etc.</li><li>Oversees and coordinates Manufacturing and Packaging operations.&nbsp;</li></ul> Responsibilities: Key Accountabilities: <ul><li>Accountability Lead and supervise operations in solid dosage manufacturing and packaging to ensure adherence to Master Formula and Master Packaging Records, SOP’s, and regulatory requirements (FDA, etc.).</li><li>Communicate with department leadership, set the shift schedule, and conduct shift huddle/communication at start of shift to ensure effective communication between shifts.</li><li>Ensure timely execution of production schedules.</li><li>Monitors manufacturing and packaging processes to ensure schedule is met within standards.</li><li>Review and complete shift documentation, including batch documentation, logbooks, etc.</li><li>Coordinate with Engineering and Quality Assurance to address any equipment issues that occur during the shift Support investigations for deviations that occur during the shift.</li><li>Assist in determining and implementing CAPA.</li><li>Provide training, guidance, and performance feedback for shift employees.</li><li>Ensure training requirements are met.</li><li>Support employee development and cross-training.</li><li>Executes procedures to complete tasks in a compliant and safe manner.</li></ul> Continuous Improvement <ul><li>Captures and reports metrics; troubleshoots downtime to increase operational efficiency.</li><li>Lead or participate in Continuous Improvement projects.</li><li>Troubleshoots and resolves process issues.</li></ul> Issues &amp; Deviations <ul><li>Performs defect evaluations and initiates production events.</li><li>Identifies, reports, and suggests resolutions for processing related issues.&nbsp;</li><li>Assists in the investigation of unplanned deviations.</li></ul> Teamwork and Collaboration <ul><li>Provides priorities for the off-shift operations, focusing resources on priority products.</li><li>Interfaces with supervisors and/or Quality personnel to inform of deviations or other line issues.</li><li>Continuous Training Ensures personnel are current with training requirements.</li><li>Stays current on SOPs and cGMPs.</li><li>Continuous Safety &amp; Compliance Contribute to safety audits.</li><li>Ensures out manufacturing/packaging activities safely, as required, on a daily basis.</li><li>Follows all safety and compliance procedures and participates in required training.</li><li>Adheres to all cGMP compliance/regulatory mandates and quality requirements.</li><li>Participate in safety teams, start-up discussions, incident debriefs, etc.</li><li>Ensures compliance with SOPs, Policies and Procedures as required by the Company and regulatory agencies.</li><li>Misc Other related duties as assigned to meet departmental and Company objectives.&nbsp;</li></ul> Requirements: Qualifications Education &amp; Experience: <ul><li>Minimal acceptable level of education, work experience and certifications required for the job Bachelor’s degree in pharmacy, Chemistry, Engineering, or a related discipline preferred, relevant experience my substitute.</li><li>Minimum of 3 years supervisory experience in pharmaceutical solid dosage manufacturing/packaging.&nbsp;</li><li>Knowledge Proficiency in a body of information required for the job e.g.</li><li>Knowledge of FDA regulations, GMP/GLP/GCP, Lean Manufacturing, Six-Sigma, etc.</li><li>Thorough knowledge of cGMP and FDA regulations.</li><li>Thorough knowledge of manufacturing and packaging operations.&nbsp;</li></ul> Skills &amp; Abilities: <ul><li>Often referred to as “competencies”, leadership attributes, skills, abilities or behaviors that may be enterprise, functional or job specific e.g. coaching, negotiation, calibration, technical writing etc.</li><li>Demonstrated leadership, communication, and decision-making skills.</li><li>Ability to oversee and manage the daily operations of manufacturing and packaging. Ability to monitors processes to ensure schedule is met within standards.</li><li>Ability to analyze metrics and troubleshoot downtime.&nbsp;</li><li>Effectively interfaces with Quality Assurance to inform of deviations or other line issues.</li><li>Demonstrates the ability to work in collaboration with others as a part of a team.</li><li>Ability to lead in Continuous Improvement projects.</li><li>Possess technical writing skills.&nbsp;</li><li>Physical Requirements Physical &amp; mental requirements e.g. lift 40 pounds, walk across plant/warehouse, business travel (% of time), driving as part of work responsibilities, etc.</li><li>Must be able to stand for long periods of time (8- or 12-hour shifts), lift at least 35 pounds, climb ladders, wear a dust mask or respirator and pass associated respirator tests and/or requirements, and be able to wear all required PPE, including safety glasses, ear plugs, and safety shoes.</li></ul>

Role Description: <ul><li>A concise overview of the job The Supervisor, Quality Control is responsible for overseeing the day-to-day operations of the QC raw material testing group.</li><li>Supervision and enforcing cGMP’s, GLP’s, conducting investigations, method transfers, verifications of compendia methods and training of new employees.</li><li>All incumbents are responsible for following applicable Division &amp; Company policies and procedures.</li><li>Scope of Authority - span of control (work unit, site, department, division, etc.), monetary value of budget/spend authority (capital, operating, etc.), P&amp;L responsibility, etc.</li><li>Supervisory responsibilities within a single site.</li></ul> Responsibilities: <ul><li>QC Lab Management- Supervise day-to-day operations of QC Laboratory to ensure that cGMP’s, GLP’s and all other applicable compendial requirements are met.</li><li>Ensure that the testing is done as per the approved monograph procedures, investigate and take corrective actions, document investigation findings and coordinate the approval process of investigations.</li><li>Interact with Planning, Purchasing, Supply Chain, Production, QA for timely release of raw materials, excipient and packaging components.</li><li>Coordinate Analytical Methods Transfer projects. Identify and implement procedures to reduce cost of goods.</li><li>Develop systems and processes for proactive management of laboratory logistics and instrumentation.</li><li>Oversee ordering of lab supplies in observance of Departmental Budget constraints.</li><li>Workload Management- Coordinate workload sharing with other groups in QC and develop action plans to improve the working environment and for maximization of laboratory efficiency.</li><li>Prepare monthly report of the issues, work done, any employee related issues and conduct bi-weekly audits of the analyst’s notebooks.</li><li>SOPs - Review/update SOP’s, procedures and monographs for the QC Group as needed.</li><li>Review and comment on the articles affecting QC in the USP Supplements and Pharmacopeial Forums.</li><li>Conduct periodic audits of the analyst notebooks and instrument logbooks to ensure compliance of cGMP’s.</li><li>Staff Development-Evaluate potential candidates for QC; performance evaluation of direct reports.</li><li>Provide training in all procedures/instrumentation/techniques, including but not limited to HPLC, UV-Vis, IR, and Raw Material, Finished Product, Stability testing. 15% Total	100% Qualifications&nbsp;</li></ul> Requirements: Education &amp; Experience <ul><li>Minimal acceptable level of education, work experience and certifications required for the job</li><li>BS in chemistry or related discipline with 10+ years’ experience in pharmaceutical testing OR MS in Chemistry or related discipline with 7+ years’ experience in pharmaceutical testing.</li><li>3+ years’ QC lab supervisory experience in pharmaceutical industry.</li><li>Demonstrated management and leadership experience with strong interpersonal and influencing skills.</li></ul> Knowledge&nbsp; <ul><li>Proficiency in a body of information required for the job e.g. knowledge of FDA regulations, GMP/GLP/GCP, Lean Manufacturing, Six-Sigma, etc.</li><li>Expert knowledge of applicable safety and standards guidelines, such as SOP, cGMP, GLP, DEA regulations and/or SDS.</li><li>Strong knowledge and proficiency required with laboratory techniques/instruments, such as HPLC, GC, analytical balance, pipette, burette, oven, UV-vis spectrophotometer, dissolution tester, pH meter, etc.</li><li>Strong knowledge and proficiency preferred with Empower, Track Wise and Labware LIMS.</li></ul> Skills &amp; Abilities	 <ul><li>Often referred to as “competencies”, leadership attributes, skills, abilities or behaviors that may be enterprise, functional or job specific e.g. coaching, negotiation, calibration, technical writing etc.</li><li>Organizational Support- Follows policies and procedures; completes administrative tasks correctly and on time; supports organizations goals and values; benefits organization through outside activities; supports affirmative action and respects diversity.</li><li>Leadership - Exhibits confidence in self and others; inspires and motivates others to perform well; effectively influences actions and opinions of others; accepts feedback from others; gives appropriate recognition to others.</li><li>Supervising People- Includes staff in planning, decision-making, facilitating and process improvement; takes responsibility for subordinates activities; is available to staff; provides regular performance feedback; develops subordinates skills and encourages growth; solicits and applies customer feedback (internal and external); fosters quality focus in others; improves processes, products and services.; continually works to improve supervisory skills.</li><li>Quality - Demonstrates accuracy and thoroughness; looks for ways to improve and promote quality; applies feedback to improve performance; monitors own work to ensure quality.</li><li>Demonstrated flexibility in carrying out varied assignments in a high-quality work environment.</li><li>Excellent written and oral communications skills with a strong emphasis on organizational capabilities.</li></ul> Physical Requirements	 <ul><li>Physical &amp; mental requirements e.g. lift 40 pounds, walk across plant/warehouse, business travel (% of time), driving as part of work responsibilities, etc.</li><li>Employee is frequently required to use hands to handle or feel.</li><li>The employee must occasionally lift and/or move up to 25 pounds. Specific vision abilities required by this job include close vision and color vision.</li><li>The noise level in the work environment is usually moderate.</li><li>The work environment is representative of a group laboratory environment.</li><li>QC Lab Management, Workload Management, SOPs, Staff Development</li></ul>

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12 incident investigation Jobs found

Senior Quality Specialist

Cost Accountant

Safety, Health & Environment Manager

Technical Support Specialist

EHS Manager

Site Investigation Lead, Quality Assurance

HR Transaction Delivery Analyst

Consulting Principal AWS Cloud Engineer

Operations Supervisor

Quality Control Supervisor

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Skills

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Location

Jobtitle

12 incident investigation Jobs found

Senior Quality Specialist

Cost Accountant

Safety, Health & Environment Manager

Technical Support Specialist

EHS Manager

Site Investigation Lead, Quality Assurance

HR Transaction Delivery Analyst

Consulting Principal AWS Cloud Engineer

Operations Supervisor

Quality Control Supervisor

WhiteCrow WhiteCrow is on a mission to connect companies with the best talent across the globe.

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WhiteCrow is on a mission to connect companies with the best talent across the globe.