QC Lab Sample Coordinator

Senior Microbiology Technician

Front of House Coordinator

QC Laboratory Manager

Key Account and E-Commerce Manager

NPD Strategic Sourcing Analyst

system engineer

Reference Standard Coordinator

Manufacturing Team Leader

Manager, Operations

Responsibilities: Sample Management <ul><li>Performs QC sample/reference standard/chromatographic column receipt, processing, distribution for testing and storage.</li><li>Performs QC sample reconciliation and disposal.</li><li>Tracks inventory of product samples, stability samples, and test materials in the lab.</li><li>Uses laboratory software for sample, reference standard, chromatographic column management.</li><li>Verifies accuracy of labeling/documentation provided with samples.</li><li>Informs QC Coordinator if chemical or reference standard is expired for removal from laboratory area.</li><li>Send samples for outside testing. Submit samples to the appropriate labs for testing.</li><li>Create and maintain reports including quality data trending, informational spreadsheets, laboratory log spreadsheets.</li><li>Compile a list of necessary laboratory supplies specifically reference standards, contacting vendors to obtain quotes.</li><li>Uses the purchasing system to procure laboratory supplies.</li><li>Provide status updates to QC management and other departments regarding the submission of samples.</li><li>Maintain a safe work environment by following standards and procedures and complying with legal regulations.</li></ul> Lab Equipment <ul><li>Maintains, operates equipment and instruments supporting sample processing.</li><li>Provides general laboratory support such as routine instrument cleaning/preventative maintenance/calibration, sample receiving, chemical inventory, document filing and housekeeping.</li><li>Works with internal resources to maintain lab in an optimal state. Cleans lab working surfaces and disposes of any excess chemicals, solutions, solvents, etc. in the special waste containers for each class of waste chemicals.</li><li>Under close supervision, learns to troubleshoot basic instrument problems.</li></ul> Investigations&nbsp; <ul><li>Escalates any trends/events to the QC Lab Manager.</li><li>Escalates any sample and reference standard documentation issues to the QC Lab Manager.</li><li>With guidance, participates in OOS/OOT/NOE and other investigations.</li><li>Assists, as and when needed, scientists working in the laboratory.</li><li>May assist in drafting, editing, and reviewing SOPs.</li></ul> Training <ul><li>Maintains assigned training records current and in-compliance.</li><li>May assist in the training of laboratory staff.</li></ul> Compliance&nbsp; <ul><li>Performs assigned work in a timely and safe manner conforming to regulatory, company and compendia requirements within pharmaceutical manufacturing setting.</li><li>Documents accurately data generated in notebooks/worksheets/LIMS in compliance with SOPs.</li><li>Follows internal processes related to controlled substances.</li></ul> Safety <ul><li>Follows EH&amp;S procedures to ensure a safe work environment.</li><li>Follows all applicable safety and standards guidelines, such as SOPs, cGMP, DEA regulations good documentation practice and/or MSDS.</li></ul> Requirements: Education &amp; Experience <ul><li>College graduate, preferably in a Science related field.</li><li>Laboratory experience related to sample management preferred.</li></ul> Knowledge <ul><li>Basic knowledge of sample management in a laboratory environment.</li><li>Some knowledge of applicable safety and standards guidelines: SOP, cGMP, GLP, DEA regulations and/or MSDS.</li><li>Competency in Microsoft Office Suite.</li><li>Proficiency with computer savvy.</li></ul> Skills &amp; Abilities <ul><li>Ability to display and analyze data in a logical manner.</li><li>Good verbal and written communication skills as well as good computer skills.</li><li>Attention to details and accurate record keeping.</li><li>Establish and maintain cooperative working relationships with others.</li><li>Solid organizational skills</li><li>Ability to take initiative, set priorities and follow through on assignments.</li></ul> Physical Requirements <ul><li>Extended periods of sitting, standing, walking, reaching, climbing/balancing, kneeling/crouching/crawling, looking at monitor for extended periods, moderate noise levels and potential business travel.</li><li>Work is in an FDA and DEA-regulated pharma lab environment with risk of exposure to various chemicals.</li><li>Must occasionally lift and/or move up to 15-25 lbs.</li><li>Ability to wear personal protective equipment, including respirators, gloves, etc.</li><li>Specific visions abilities are required by this job include close vision and color vision</li><li>Ability to occasionally tolerate significant differences in temperature and/or humidity for short periods.</li></ul>

Responsibilities: <ul><li>Perform and oversee complex microbiological activities, including environmental monitoring (viable and non-viable), utility sampling (e.g., water, compressed gases), and aseptic process support in areas utilizing isolator technology.</li><li>Conduct and review microbiological testing for bioburden, endotoxin (LAL), sterility, and microbial identification on raw materials, in-process samples, and final products.</li><li>Support and lead aspects of aseptic process simulations (media fills) including planning, execution, incubation, and interpretation of results within isolator systems.</li><li>Assist in the startup and qualification of the microbiology laboratory including equipment qualification, SOP development, method verification/validation, and environmental monitoring qualification.</li><li>Contribute to investigations, non-conformances, and microbiological excursions by providing subject matter expertise and supporting root cause analysis and CAPA implementation.</li><li>Ensure accurate and timely documentation of laboratory data in compliance with data integrity principles and cGMP guidelines.</li><li>Mentor and provide technical guidance to junior microbiology staff, fostering a culture of scientific excellence, compliance, and continuous learning.</li><li>Maintain laboratory readiness for internal and external audits by following and enforcing good laboratory practices and cGMP expectations.</li><li>Participate in ongoing improvements to laboratory procedures, contamination control strategies, and sterility assurance programs.</li><li>Interface cross-functionally with Quality Assurance, Manufacturing, Validation, and Engineering to support cleanroom and equipment qualifications, isolator decontamination cycles, and site expansion activities.</li></ul> Requirements: Qualifications/Experience: <ul><li>Bachelor’s degree in microbiology, Biology, Life Sciences, or a related field.</li><li>Minimum of 3-5 years of microbiology laboratory experience in a cGMP pharmaceutical or biotechnology manufacturing environment.</li><li>Experience with isolator-based sterile manufacturing processes and aseptic support activities is strongly preferred.</li><li>Working knowledge of cGMPs, FDA and EU Annex 1 requirements, and microbiological standards (USP &lt;61&gt;, &lt;62&gt;, &lt;71&gt;, &lt;85&gt;, &lt;1116&gt;).</li><li>Experience supporting laboratory equipment startup, qualification, and routine maintenance preferred.</li><li>Prior experience with high potent APIs and/or controlled substances is desirable.</li></ul> Skills/Competencies: <ul><li>Advanced technical skills in environmental monitoring, microbial testing, and aseptic processing support.</li><li>Strong documentation and data integrity skills with a meticulous attention to detail.</li><li>Demonstrated ability to troubleshoot microbiological and laboratory equipment issues.</li><li>Effective time management and prioritization skills in a fast-paced environment.</li><li>Strong communication skills with the ability to train and mentor junior staff.</li><li>Proactive, collaborative, and compliance-oriented mindset.</li><li>Comfortable working in cleanroom environments and adhering to gowning and contamination control protocols.</li></ul>

Role Description: <ul><li>The driving force behind the scanning platform at Client Dive into the forefront of innovation with our Gateway Security team, where we scan massive volumes of email traffic for our customers! Our pioneering Email Platform pushes on the boundaries of what’s possible, leveraging the latest technologies and tooling in AWS. Why Join Our Team? “The Gateway Security team, within the Threat Protection group, is responsible for developing the cutting edge scanning technology at the heart of Client protection stack, scanning over 2 billion emails, files, and URLs daily.</li><li>If you’re interested in solving customer challenges at immense scale, then this is the role for you!”</li></ul> Responsibilities: <ul><li>Initial point of contact for all Client in the Bengaluru office.</li><li>Be part of the global Client facilities team and assist the teams in other regions as required.</li><li>Coordinate first aid and fire safety as per building and statutory requirements.</li><li>Meet and greet clients and visitors, ensure Client visitor processes are followed.</li><li>Ensure effective and professional telephone communications by answering any incoming calls, taking messages and/or forwarding to the individual.</li><li>Sort daily post/deliveries/couriers, manage invoicing from landlord and suppliers.</li><li>Arrange catering for meetings and events as required.</li><li>Ensure daily checks of offices and kitchen areas, purchase office consumables as required, including beverages and food items and refreshment facilities.</li><li>Ensure the office is consistently kept in the best state including periodic checks of cleaning and maintenance with landlord and appointed contractors.</li><li>Liaise with building management, submitting maintenance request’s and raising permits.</li><li>Work with Regional IT and liaise with regional team and suppliers, including issuance of staff access passes, assist with supply and return of IT equipment and access for maintenance contractors.</li><li>Help out with planning of company events.</li><li>Within this position, the successful candidate will also be tagging assets, taking count of returned items - fixed asset management duties are listed in the job spec.</li><li>Including: new assets being purchased and a log of asset tags will need to be maintained.&nbsp;</li></ul> Requirements: <ul><li>2 – 4 years of administrative experience.&nbsp;</li><li>Proficiency with Microsoft Office, Word, Excel, and PowerPoint&nbsp;</li><li>Outstanding organizational skills, accuracy and attention to detail and the ability to multitask.</li><li>Written and verbal skills with strong grammatical, proofreading, typing and note taking skills.</li><li>Ability to work independently, flexibly and use discretion.</li><li>Excellent interpersonal skills, including a pleasant positive demeanor and a proactive approach.</li><li>A solid understanding of the goals and objectives of the business and their own personal goals.</li><li>Recognize that customer satisfaction is a principle measure of our business and our values.</li><li>Instinctively find practical solutions to complex problems.</li><li>Expect to encounter change and take ownership of your job.&nbsp;</li><li>Find new ways to win and share those victories with the team.&nbsp;</li></ul>

Responsibilities: <ul><li>Establish and lead the QC laboratory, including analytical and microbiological functions, supporting sterile injectable IV bag production.</li><li>Oversee all testing activities: raw material, in-process, finished product, and stability testing, in compliance with applicable cGMP and regulatory requirements.</li><li>Support and manage startup, qualification, calibration, and maintenance of all QC lab equipment and systems to ensure operational readiness and regulatory compliance.</li><li>Develop and enforce strong data integrity practices, including procedures, training, and routine monitoring of laboratory systems and documentation.</li><li>Build and maintain a scientifically sound, compliant laboratory environment capable of supporting high-potent APIs and controlled substances.</li><li>Hire, train, and mentor laboratory personnel to ensure technical capability and compliance with laboratory and safety procedures.</li><li>Implement and maintain robust systems for documentation (SOPs, protocols, specifications), investigations (OOS, deviations), and CAPA management.</li><li>Lead and support analytical method transfers, validations, and technical investigations in collaboration with cross-functional teams.</li><li>Oversee microbiology operations, including environmental monitoring, utility sampling, sterility testing, and microbiological release activities.</li><li>Ensure inspection readiness and represent QC in audits, PAIs, and regulatory inspections.</li><li>Collaborate cross-functionally with QA, Validation, Engineering, Manufacturing, and Regulatory to ensure alignment and compliance across the site.</li><li>Ensure adherence to safety protocols, especially in handling high-potent materials and controlled substances.</li><li>Establish laboratory KPIs and drive continuous improvement in performance, compliance, and operational efficiency.</li></ul> Requrements: Qualifications / Experience: <ul><li>Bachelor’s or Master’s degree in Chemistry, Microbiology, or related scientific discipline.</li><li>8–12 years of pharmaceutical QC laboratory experience, including 3–5 years in a leadership role.</li><li>Experience with sterile injectable manufacturing, high-potent APIs, and controlled substances is required.</li><li>Deep knowledge of cGMP, FDA, ICH, USP, and applicable global regulatory standards.</li><li>Experience with startup or greenfield sites and laboratory buildouts preferred.</li><li>Demonstrated experience with method transfer, validation, and technical problem-solving.</li><li>Experience establishing equipment lifecycle programs, including qualification and maintenance.</li></ul> Skills / Competencies: <ul><li>Strong leadership with ability to build and develop high-performing lab teams.</li><li>Excellent technical knowledge in analytical and microbiological testing.</li><li>Deep understanding of data integrity principles and enforcement of best practices.</li><li>Proficiency in laboratory systems (LIMS, CDS, ELN) and equipment qualification.</li><li>Ability to manage complex lab operations in a startup environment.</li><li>Strong project management, documentation, and communication skills.</li><li>Commitment to patient safety, quality, and regulatory compliance.</li></ul>

Role Desscription: <ul><li>The key account and e-commerce manager is responsible for driving the execution of brand and commercial strategies across digital sales channels, ensuring excellence in online presence, promotion and conversion.</li><li>This role acts as the key interface between marketing, sales and eRetailers, translating brand &amp; commercial objectives into shopper-centric initiatives that enhance visibility, engagement, and sell out performance in the digital environment.</li></ul> Responsibilities: <ul><li>Connecting with distributors to drive sales in pure e-commerce players (Lazada, Shopee etc).</li><li>Ensure excellence in execution in e-commerce across pure players and also retail e-commerces.</li><li>Omnichannel execution. Ensure 360 activation of IMC in e-commerce platforms across focus markets in SSEA.</li></ul> Key Accountabilities <ul><li>Digital Channel Strategy Execution: translate brand and sales strategies into tailored online plans for each digital customer (marketplaces, B&amp;C, quick commerce). Align and execute commercial calendars, launches, and campaigns in collaboration with Sales and Marketing teams.</li><li>% of planned activities executed according to the digital commercial calendar.</li><li>Internal alignment score with Sales and Marketing (e.g., internal NPS or feedback in JBP sessions).</li><li>Number of campaigns successfully launched by channel/platform.</li></ul> <ul><li>Visibility and Conversion: Ensure best-in-class product content, imagery, and search optimization across all eRetail platforms.</li><li>Deploy digital trade initiatives (e.g., banners, activations, product sampling) to increase brand visibility and conversion.</li><li>Share of Search (SoS) for top keywords per platform.</li><li>Conversion Rate (CVR) by priority product and platform.</li><li>% of planned digital assets (e.g., banners, feature slots) executed on time.</li></ul> <ul><li>Promo &amp; Investment Planning: Coordinate digital promotional mechanics in line with budget, ROI, and brand guidelines.</li><li>Monitor competitive pricing and promotions to adjust plans accordingly.</li><li>ROI of promotional campaigns (% return on investment).</li><li>Budget adherence rate (% of trade digital budget spent as planned).</li><li>Sell-out growth during promotional periods (vs. pre-promo baseline or LY).</li></ul> <ul><li>Performance Analysis &amp; Reporting:</li><li>Track and analyze key performance indicators (e.g., sell-out, share of shelf, conversion rates, media ROI).</li><li>Generate actionable insights to optimize future campaigns and investments.</li><li>Accuracy of reported data (target: &lt;5% margin of error).</li></ul> <ul><li>Content &amp; Assortment Management:</li><li>Maintain accurate and complete product information, ensuring consistent presence across platforms.</li><li>Support in defining digital assortment priorities and product visibility strategies by platform.</li><li>% of SKUs with compliant, high-quality content live on each platform.</li><li>Time to market for new product content.</li><li>Assortment compliance rate per retailer (e.g., % of priority SKUs listed).</li></ul> Requirements: <ul><li>Experience Capability.</li><li>Graduation Complete.</li><li>MBA (Differential).</li></ul> Language <ul><li>Advanced English</li></ul> Discipline of Knowledge. <ul><li>Administration, Economics, Marketing</li></ul> Specific knowledge of the team you lead. <ul><li>Previous experience in FMCG Industries in E-commerce or in pure e-commerce players.</li><li>Proficiency in Excel and Power Point.</li><li>Project management.</li><li>Knowledge of Tableau (BI and Dashboards) or programming language.</li></ul> Organization <ul><li>Analytical – Working with data Management.</li></ul> Communication <ul><li>Teamwork.</li><li>Resilience and self-motivation.</li><li>Logical reasoning.</li><li>Ability to prioritize and sense of urgency.</li><li>Ability to execute.</li></ul>

Responsibilities: <ul><li>Focal point of all supply chain initiatives associated with NPD for assigned product lines.</li><li>Develop &amp; implement all integrated supply chain activities for New Product Introduction.&nbsp;</li><li>Fully understand new project background information, including project footprint plan, project commercial information in terms of sample/ramp up/MP schedule and cost target, BOM components technical requirement and etc.&nbsp;</li><li>Develop strategic vision for supply base at conception phase of new products.</li><li>Improve time to market including quotation and sampling activities, driving material standardization,&nbsp;</li><li>Arrange RFQ, analyze and organize SSR meeting to award business based on cost, lead time, core competency, and location.</li><li>Ensure vendor quoted costs meet BOM cost Landing Zone targets.&nbsp;Work with commodity management team and should cost team to achieve the target.</li><li>Design first-time-right supply chains for new products / platforms during development phase</li><li>Promote Dual Source and Localization in new project phase.&nbsp;</li><li>Work with commodity management to leverage supplier capabilities and improve collaboration among company and supply base</li><li>Improve overall service from Procurement to Internal customer e.g. project managers and project core team members.&nbsp;</li><li>Provide strong support for company manufacturing plant(s) for NPI.&nbsp;</li><li>Holds Voice of Customer Sessions with internal customers and utilizes feedback to improve team performance and supply base service.&nbsp;</li><li>Complete special projects as directed by regional or global management.</li></ul> Requirements: <ul><li>10+ years’ experience in NPD Sourcing or project management role.</li><li>Proven Experience in New Product Introduction as a sourcing analyst in a global company is preferred</li><li>Experience in sourcing mechanical components such as stamping, molding, diecasting, machining, and electronics components such as PCB, PCBA, cable. Technical understanding of these commodities is required.</li><li>Education: Bachelor level degree in Business, Supply Chain, Sourcing/ Procurement or related field.&nbsp;Advanced degree a plus.</li><li>Strong communication skills both written and verbal English.</li><li>Self-motivated individual with a positive attitude, able to work well with international teams and individuals.</li><li>Strong analytical skills, comprehensive and logic thinking.&nbsp;</li><li>Demonstrated negotiation skills.</li><li>Proficient in MS office suite; advanced Excel, Power point.</li><li>Lean PD experience is a plus.</li><li>Previous SAP experience or training a plus.</li></ul>

Responsibilities: <ul><li>Provide application L1/L2 support and system checks (CPU, disk usage, logs, services)</li><li>Troubleshoot and resolve system and application issues, and provide on-site technical support to ensure timely resolution and minimal disruption to business operations</li><li>Monitor application health and system alerts, escalating issues as needed</li><li>Log incidents and service requests in the ticketing system, ensuring timely resolution</li><li>Coordinate with L3 teams and vendors for issue escalation and follow-up</li><li>Perform routine maintenance tasks, such as application updates, patching, and backups</li><li>Maintain clear documentation of issues, fixes, and procedures</li><li>Participate in system testing, deployment, and post-deployment support activities</li><li>Assist in user access management and configuration </li><li>Requirements:</li><li>Diploma/Degree in Electrical Engineering, Computer Science, Communications Engineering or equivalent</li><li>Minimum 2 years in application maintenance, support or server infrastructure setup</li><li>Experience participating in Kubernetes cluster projects, with proficiency in using relevant commands to check application logs</li><li>Experience with at least two of the following Virtualization Technology/Platforms: VMware, Xen, KVM, OpenStack, Cloud Stack, Azure Stack</li><li>Experience with cloud orchestration, configuration management and auto-scaling techniques</li><li>Thorough knowledge of networking, routers, switches, and WiFi setup</li><li>Hands on experience in deploying ceph using different file system such as object storage, rbd, cephfs storage</li><li>Good knowledge of storage technologies, such as NAS, SAN, SDS</li><li>Experience with automation tools such as Salt/Chef/Puppet/Ansible</li><li>Experience with load balancing setup for TCP/IP, HTTP, DNS, routings.</li><li>Experience in using software version control</li><li>Knowledge of IT security standards, for instance from CIS or IM8.</li><li>Experience in IT security policy management and enforcing IT security</li><li>Knowledge of computer hardware components and ability to restore faulty servers to working condition.</li><li>Experience in coding or scripting languages such as bash, windows batch script, powershell, perl, python, etc.&nbsp;</li></ul>

Responsibilities: Sample Management <ul><li>Performs QC reference standard/chromatographic column receipt, processing, distribution for testing and storage.</li><li>Performs QC reference standard reconciliation and disposal.</li><li>Tracks inventory of reference standards in the lab.</li><li>Uses laboratory software for reference standard, chromatographic column management.</li><li>Verifies accuracy of labeling/documentation provided with reference standards.</li><li>Informs QC Coordinator if chemical or reference standard is expired for removal from laboratory area.</li><li>Coordinates, with lab management, in-house qualification of reference standards. Submit samples to the appropriate lab groups for testing.</li><li>Create and maintain reports including quality data trending, informational spreadsheets, laboratory log spreadsheets.</li><li>Compile a list of necessary laboratory supplies specifically reference standards, contacting vendors to obtain quotes.</li><li>Uses the purchasing system to procure reference standards and laboratory supplies.</li><li>Provide status updates to QC management and other departments regarding the status of reference standard inventory.</li><li>Maintain a safe work environment by following standards and procedures and complying with legal regulations.</li></ul> Lab Equipment <ul><li>Maintains, operates equipment and instruments supporting reference standard processing.</li><li>Provides general laboratory support such as routine instrument cleaning/preventative. maintenance, reference standard/sample receiving, chemical inventory, document filing and housekeeping.</li><li>Works with internal resources to maintain lab in an optimal state. Cleans lab working surfaces and disposes of any excess chemicals, solutions, solvents, etc. in the special waste containers for each class of waste chemicals.</li><li>Under close supervision, learns to troubleshoot basic instrument problems.</li></ul> Investigations <ul><li>Escalates any trends/events to the QC Lab Manager.</li><li>Escalates any reference standard documentation issues to the QC Lab Manager.</li><li>With guidance, participates in OOS/OOT/NOE and other investigations.</li><li>Assists, as and when needed, scientists working in the laboratory.</li><li>May assist in drafting, editing, and reviewing SOPs.</li></ul> Training <ul><li>Maintains assigned training records current and in-compliance.</li><li>May assist in the training of laboratory staff.</li></ul> Compliance <ul><li>Performs assigned work in a timely and safe manner conforming to regulatory, company and compendiaI requirements within pharmaceutical manufacturing setting.</li><li>Documents accurately data generated in notebooks/worksheets/LIMS in compliance with SOPs.</li><li>Follows internal processes related to controlled substances.	continuous.</li></ul> Safety <ul><li>Follows EH&amp;S procedures to ensure a safe work environment.</li><li>Follows all applicable safety and standards guidelines, such as SOPs, cGMP, DEA regulations good documentation practice and/or MSDS.</li></ul> Requirements: Education &amp; Experience <ul><li>College graduate, preferably in a Science related field.</li><li>Laboratory experience related to sample management preferred.</li></ul> Knowledge <ul><li>Basic knowledge of reference standard/sample management in a laboratory environment.</li><li>Some knowledge of applicable safety and standards guidelines: SOP, cGMP, GLP, DEA regulations and/or MSDS.</li><li>Competency in Microsoft Office Suite.</li><li>Proficiency with computers.</li></ul> Skills &amp; Abilities <ul><li>Ability to display and analyze data in a logical manner.</li><li>Good verbal and written communication skills as well as good computer skills.</li><li>Attention to details and accurate record keeping.</li><li>Establish and maintain cooperative working relationships with others.</li><li>Solid organizational skills.</li><li>Ability to take initiative, set priorities and follow through on assignments.</li></ul> Physical Requirements	 <ul><li>Extended periods of sitting, standing, walking, reaching, climbing/balancing, kneeling/crouching/crawling, looking at monitor for extended periods, moderate noise levels and potential business travel. Work is in an FDA and DEA-regulated pharma lab environment with risk of exposure to various chemicals.</li><li>Must occasionally lift and/or move up to 15-25 lbs.</li><li>Ability to wear personal protective equipment, including respirators, gloves, etc.</li><li>Specific visions abilities are required by this job include close vision and color vision.</li><li>Ability to occasionally tolerate significant differences in temperature and/or humidity for short periods.</li></ul>

Responsibilities: <ul><li>Assist and monitor employees in job performance, answer questions, maintain action log, and provide&nbsp;</li><li>input to Area Lead on employee’s job performance.</li><li>Maintain production schedules by ensuring that each line is set-up per the prescribed line layout, has proper equipment, fixturing, tools, proper prints, in-process inspection sheets, and work instructions at the beginning of each shift, after line changeover, and during the shift.</li><li>Ensure proper clean up.</li><li>Ensure proper operation and guarding of equipment, report any unsafe equipment and/or unsafe acts.</li><li>Set good examples for quality, attendance, confidentiality, professionalism and display a positive attitude.</li><li>Consistently apply the Quality System procedures and enforce company policies and safety regulations.</li><li>Complete all documentation as required by department work instructions.</li><li>Ensure all suspect or reject material is quarantined and handled per Quality System procedures.</li><li>Make decisions and accept responsibility on operations related to assigned lines.</li><li>Assist in performing and evaluating 1st piece inspections for products as directed.</li><li>Post quantity goals and turn goal results in to Area Lead</li><li>Promote teamwork within the Production Line</li><li>Work closely with production control to react to schedule changes.</li><li>Communicate all appropriate issues to Area Lead.</li><li>Ensures production paper work is processed in a timely and accurate manner.&nbsp;</li><li>Perform other related duties and assignments as required.</li></ul> Requirements: <ul><li>High School diploma or GED</li><li>Evidence of continued education &amp; training</li><li>3-12 months experience in production</li></ul>

Role Description:&nbsp; <ul><li>The purpose of this job is to oversee the production schedules in accordance with approved production instructions, standard operating procedures, while utilizing cGMP for the preparation of commercial product.</li><li>Monitor and document in a periodic performance review the performance of the production staff. Identify opportunities for process and equipment improvements.</li><li>Mentor staff and set goals and objectives for the production personnel.</li></ul> Responsibilities: <ul><li>Manufacturing Operations Management</li><li>Assure the accurate execution of cGMP/DEA documentation relative to manufacturing and packaging activities.</li><li>Assure the accurate manufacturing of bulk drug product for delivery to primary packaging without deviation.</li><li>Assure the accurate packaging of drug product in approved primary packaging components without deviation</li><li>Assure the accurate sampling of raw material and the packaging of samples for shipment as appropriate to contract testing laboratories.</li><li>Assure the accurate assessment of component inventory and reconciliation.</li><li>Assure staff training requirements are established and complete prior to the performance of process or procedure.</li><li>Assure the accurate performance of basic routine preventive maintenance of equipment and facility cleaning activities by operators.</li><li>Establish performance Goals and Objectives based on facility needs and High Corporate Standards.</li><li>Complete routine performance evaluations of staff, and recommend growth opportunities.</li><li>Assure adherence to established production schedules and monitor production performance as determined by the Plant Director.</li><li>Monitor the general safety of staff and assure safe work practices are followed by all site personnel.</li></ul> Requirements: Education &amp; Experience <ul><li>Undergraduate Degree in Pharmacy, Engineering, or equivalent in training and experience.</li><li>10 years’ experience in a pharmaceutical manufacturing environment.</li><li>Prior cGMP experience in a pharmaceutical production environment is necessary. 3-5 years’ previous supervisory experience required.</li><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></ul> Knowledge&nbsp; <ul><li>Knowledge of workplace health and safety requirements for applicable hazardous substances.</li><li>Must be able to demonstrate a high degree of understanding in the cGMP practices.</li><li>Must be able to demonstrate a high degree of understanding in the controlled drug substance regulations.</li><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></ul> Skills &amp; Abilities <ul><li>Demonstrate knowledge of the current good manufacturing practices.</li><li>Ability to convey information clearly and concisely to both individuals and groups.</li><li>Ability to troubleshoot manufacturing processes, write investigations and complete documentation.</li><li>Ensure adequate staffing and efficient workflow and provide reports and data on manufacturing activity.</li></ul> Physical Requirements	 <ul><li>This position requires working with or around hazardous substances, and is subject to work restrictions and precautions as set forth in the Safety Data Sheet, provided to all affected employees.</li><li>Ability to don personal protective equipment, if necessary. Able to walk the production floor.</li><li>This position requires working with or around hazardous substances, and is subject to work restrictions and precautions as set forth in the Safety Data Sheet, provided to all affected employees.</li><li>Ability to don personal protective equipment, if necessary.</li><li>Able to walk the production floor.</li></ul>

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13 log sampling Jobs found

QC Lab Sample Coordinator

Senior Microbiology Technician

Front of House Coordinator

QC Laboratory Manager

Key Account and E-Commerce Manager

NPD Strategic Sourcing Analyst

system engineer

Reference Standard Coordinator

Manufacturing Team Leader

Manager, Operations

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Skills

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13 log sampling Jobs found

QC Lab Sample Coordinator

Senior Microbiology Technician

Front of House Coordinator

QC Laboratory Manager

Key Account and E-Commerce Manager

NPD Strategic Sourcing Analyst

system engineer

Reference Standard Coordinator

Manufacturing Team Leader

Manager, Operations

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

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TALENT

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Contact Us

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