Scientist I, Quality Control LTS

Data Analyst

TA Specialist

Tool Room Engineer

Manufacturing Engineer

Strategic Sourcing III – Indirect Procurement

Development Engineer (Product Quality) 

Site Quality Leader

HR PARTNER II

QC Officer

Role Description: <ul><li>The Scientist, Laboratory Technical Services is primarily responsible for supporting the analytical testing requirements of commercial/pre-commercial materials and products, including method development, validation and transfer, pre-commercial/commercial testing of materials and samples in a regulated laboratory environment. </li><li>Has expert proficiency in conducting all types of physical and chemical analysis (including the most complex analysis) using all equipment. </li><li>This position will have a significant role supporting pending ANDA submissions, product launches, and method lifecycle activities to achieve company goals and initiatives. Write and review SOPs, test methods, validation protocols and reports. The Scientist also provides mentoring to Chemist.</li></ul> Responisbilities: Analysis &amp; Testing: <ul><li>Validate analytical methods for finished product and raw material release and stability testing.</li><li>Evaluates, troubleshoot/improves existing analytical methods when necessary.</li><li>Prepares method validation protocols, reports, and analytical test methods.</li><li>Performs testing to support process and formulation development (e.g. excipient, compatibility, solubility, dissolution studies, stability/impurity assessment)</li><li>Performs work to support project assigned with little oversight.</li><li>Presents analytical data to project team for review and discussion</li><li>Reviews and approves laboratory test data and documentation (e.g. notebooks, raw data and technical documentation, test methods, validation protocols, or validation report) for completeness and compliance when necessary</li><li>Reviews and evaluates drug substance supplier’s technical documents to ensure internal testing test requirements are adequate.</li><li>Uses laboratory software for analysis.</li><li>Is alert to and detects abnormalities during performances of test and reviews.</li></ul> Lab Equipment: <ul><li>Provides general laboratory support such as routine instrument cleaning/preventative maintenance/calibration, sample receiving, chemical inventory, document filing and housekeeping.</li><li>Cleans lab working surfaces and dispose of any excess chemicals, solutions, solvents, etc. in the special waste containers for each class of waste chemicals</li><li>Troubleshoots instrumentation and performs subsequent analyses</li></ul> Investigations: <ul><li>Evaluates questionable sample results, OOS, and aberrant results immediately to Supervisor and recommends a course of action related to LTS activities</li><li>Participates in root cause identification of complex laboratory investigations.</li><li>Writes, edits, and reviews SOPs and laboratory investigations</li></ul> Training: <ul><li>Train junior Scientist/Chemists on analytical techniques.</li><li>Continuously updates knowledge with respect to the latest technologies related to analytical science</li><li>Maintains assigned training records current and in-compliance</li><li>Actively assumes/demonstrates responsibility in training others in good documentation practice, practical lab skills, and chemical theories, methodologies and procedures</li></ul> Compliance: <ul><li>Identifies need for SOPs and writes or revises, as appropriate</li><li>Performs work in a timely and safe manner conforming to regulatory, company and compendial requirements within pharmaceutical manufacturing setting. Works in compliance with cGMP/cGLP regulations</li><li>Documents data generated in notebooks/worksheets/LIMS in compliance with SOPs</li><li>Takes active role in auditing laboratory logbooks/documentation to ensure compliance</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>Bachelor of Science Degree in chemistry, chemical engineering or related field with 6 years’ relevant analytical laboratory experience OR</li><li>Master’s degree in above disciplines with 4 years’ relevant analytical lab experience OR</li><li>PhD in above disciplines with some relevant analytical laboratory experience preferred</li></ul> Knowledge &amp; Skills: <ul><li>Has strong knowledge of laboratory software and has expanded knowledge of chromatographic software (e.g. Waters Empower, Agilent ChemStation and Sotax WinSotax), using custom fields, custom calculations and custom reports.</li><li>Full proficiency with various laboratory techniques/instruments: HPLC, UV-Vis, FT-IR, GC and dissolution tester, melting point apparatus, viscometer, Karl Fischer titrator, pH meter, analytical balance, etc.</li><li>Thorough knowledge of applicable safety and standards guidelines, such as FDA, ICH, SOP, cGMP, GLP, DEA regulations and/or MSDS</li><li>Has demonstrated competence in conducting chemical analyses</li><li>Strong knowledge of wet chemistry techniques</li><li>Competency in Microsoft Office Suite</li><li>Ability to critically review, analyze data, interpret information, and draw conclusions from relevant or missing information</li><li>Ability to display and analyze data in a logical manner</li><li>Strong verbal and written communication skills as well as good computer skills</li><li>Strong 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 coach less senior staff and develop laboratory skills and ability</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: Database Maintenance &amp; Support <ul><li>Assist in the maintenance of relational databases (Oracle, SQL Server).</li><li>Support schema creation, updates, normalization, and performance tuning.</li><li>Monitor data quality, identify inconsistencies, and help ensure data integrity across systems.</li></ul> Data Migration &amp; Platform Transition <ul><li>Support data extraction, transformation, and loading (ETL) during system migrations and platform upgrades.</li><li>Assist in transitioning data between legacy environments and modern systems, including Databricks.</li><li>Validate migrated data and document reconciliation results. Data Analysis &amp; Querying</li><li>Write and execute SQL queries for analysis, verification, and operational needs in Oracle and SQL Server environments.</li><li>Participate in exploratory and diagnostic analysis to uncover trends and support business decisions.</li></ul> Documentation &amp; Governance <ul><li>Maintain accurate documentation of data processes, transformations, and system behaviors.</li><li>Support compliance with organizational standards for data governance and metadata management.</li></ul> Requirements: Required Skills &amp; Qualifications <ul><li>Bachelor’s degree in Computer Science, Data Analytics, Information Systems, Engineering, or related field.</li><li>Foundational understanding of relational database concepts and SQL.</li><li>Introductory experience or coursework using Oracle, SQL Server, or similar RDBMS platforms.</li><li>Strong analytical thinking, attention to detail, and problem solving skills.</li><li>Ability to collaborate with technical teams in a fast paced environment.</li></ul> Preferred Skills &amp; Qualifications <ul><li>Exposure to Databricks or other big data / cloud analytics technologies.</li><li>Understanding of ETL concepts, data pipelines, or data transformation frameworks.</li><li>Familiarity with PL/SQL, SSIS, or other database programming tools.</li><li>Interest in learning modern data lake, delta, or virtualization technologies (e.g., Denodo).</li></ul>

Responsibilities: <ul><li>Select the desired employees and develop, implement, and monitor the programs and processes used in recruitment and selection.&nbsp;</li><li>They source, recruit, screen, interview and recommend external and/or internal candidates to staff open requisitions.&nbsp;</li><li>Utilize the services of employment agencies and/or place employment ads in appropriate sources, including the intranet, Internet, and print media.&nbsp;</li><li>Responsible for developing and implementing recruiting plans and administering talent management efforts and employee referral programs, managing the resume tracking system and ensuring consistent corporate image throughout recruiting campaigns.&nbsp;</li><li>Lead end-to-end recruitment, ensuring alignment with organizational strategy and culture.</li><li>Manage end-to-end hiring process: Source, resume screen, phone screen, schedule interviews, Offer documentation and onboarding</li></ul> Requirements: <ul><li>Minimum 6+ years of experience required for this role.</li><li>Should possess expert knowledge and innovative skills to source and attract active &amp; passive talent from different sourcing channels (job boards, social media, referrals and local outreach to identify potential candidates</li><li>Communication and Stakeholder management is key to be successful in this role as you work with global stakeholders and matrix organization</li><li>Good understanding of the engineering manufacturing industries in the local market, able to map talents, develop business intelligence for sourcing strategies and techniques</li></ul> Qualification <ul><li>Experience in handling end-to-end Talent Attraction Process [Source to Onboard]</li><li>Be able to develop Recruiting Strategies basis the skill demand and complexities</li><li>Expert knowledge and Hands-on in preparing market research, Market/Talent mapping using various tools such as Talent Neuron, Draup, LinkedIn Talent Insight</li><li>Data driven: able to analyse, slice &amp; dice data, develop insights from data and be able to make decisions to drive hiring strategies</li></ul>

Responsibilities: People Management and Development: <ul><li>Allocate and balance work across direct reports.</li><li>Review and provide timely performance feedback to direct reports.</li><li>Mentor, develop and motivate them.</li><li>Resolve people issues in the team in order to achieve targeted department performance and enhance staffs capability and working passion.</li></ul> Toolroom Production Management <ul><li>Develop toolroom production plan.</li><li>Allocate manpower based on toolroom production plan.</li><li>Monitor toolroom production plan execution and product quality.</li><li>Monitor 5S, ISO9000, , security discipline execution.</li><li>Check and monitor production report in order to ensure toolroom production operation run smoothly and improve product quality, production efficiency, on time delivery and reduce product scrap rate.</li></ul> Continuous Improvement: <ul><li>Improve toolroom related processes.</li><li>Review staff reasonable suggestion and customer complain and push improvement action plan implementation.</li><li>Evaluate and introduce new equipment, technology and materials in order to improve toolroom production operation efficiency.</li></ul> Requirements: <ul><li>Diploma/Degree in Mechanical Engineering or equivalent.&nbsp;</li><li>3 years toolroom related work experience.</li></ul>

Responsibilities: <ul><li>Responsible for various KPI’s pertaining manufacturing engineering and Team Management skills is must.</li><li>Responsible for assembly Process, Tool Design development, (New &amp; Old tools) Qualification and Trial</li><li>Improves manufacturing efficiency by analyzing planning workflow, space requirements, and equipment layout</li><li>Work with Global COE Assembly to drive continuous improvement in Assembly Technology / Process</li><li>Maintain proper documentation and for all assembly tooling, Spares and Process Set-up&nbsp;</li><li>Ensure all Tooling / automation design drawings (Soft &amp; Hard Copy) are up to date.</li><li>Impart trainings and development for new joiners, Technical Trainees etc.</li><li>Coordinate with Manufacturing Engineer for new product development and process improvement.</li><li>Assessing resource requirements and opportunity for Automation and Process Productivity improvement</li><li>Review of deployment</li><li>Review ISO documents and update, Engage in ISO audits.</li><li>Visit vendors for Assembly tooling assessment (Capability, Know How &amp; Capacity)</li><li>Monitoring of AM and PM and Effectiveness&nbsp;</li><li>Able to run the machine and instruct and train technicians to run the machine</li><li>CCD and PLC and Electrical Knowledge Preferably</li></ul> Requirements: <ul><li>Bachelor in Mechanical Engineering major or Electrical Engineering</li><li>10+ years’ experience and practitioner in the automation assembly and Tooling Design &amp; Development</li><li>CAD Knowledge Must, preferably Pro E / Creo &amp; Auto-cad, Solidworks, HMI (Human Machine interface).</li><li>DFM analysis, New automation or manual assembly / Tooling RFQ.</li><li>Assembly line Tooling &amp; Tool Debugging Knowledge.&nbsp;</li><li>Computer Knowledge, MS Office etc, SAP knowledge added advantage</li><li>Integrity; Accountability; Communication; Outgoing&nbsp;</li><li>Ergonomic and lean manufacturing practitioner</li><li>Advance digital acumen, MES (Manufacturing Execution System) and traceability.</li></ul>

Responsibilities: <ul><li>Develop and execute procurement strategies to meet production and project requirements.</li><li>Analyse and provide feedback to appropriate departments on part status / requirements for fulfilling customer demand.</li><li>Manage delivery of critical component parts and product delivery with suppliers and contract manufacturing and critical supply partners to meet customer requirements.&nbsp;</li><li>Escalation of any issues to relevant sourcing analyst.</li><li>Monitor &amp; reporting KPI targets with actions– delivery on time, confirmation of purchase orders.</li><li>Invoice processing, resolving blocked invoices &amp; amendments of purchase orders</li></ul> Requirements: <ul><li>Educational Degree, Bachelor or above, Engineering background is preferred.</li><li>Minimum 5 – 7 years of experience in indirect procurement, experience in manufacturing company is a must.</li><li>Experience in at least 2 commodities including MRO, Facility, Automation line, HR services.</li></ul>

Responsibilities: Customer Quality &amp; Technical Ownership: <ul><li>Act as the primary technical experts working closely with GQM, KQM, FSE, and internal stakeholders.</li><li>Lead customer complaint investigations, including root cause analysis using structured methodologies (e.g. 5 Whys, Fishbone, 8D), and ensure effective corrective and preventive actions (CAPA).</li><li>Ensure high-quality failure analysis (FA) reports supported by strong technical justification; challenge and close invalid or non-reproducible cases with data-driven rationale.</li><li>Drive fast response, structured escalation, and effective containment actions to improve response time and customer confidence.</li><li>Clearly translate customer complaints into technical, reliability, and risk-based problem statements.</li><li>Review customer quality documentation, including FAI, First Lot Approval, control plans, and inspection reports.</li><li>Ensure out-of-control situations are managed effectively through well-defined OCAPs, including timely containment and recovery actions.</li><li>Maintain high standards for 8D reports and monitor closure turnaround time to meet customer expectations.</li><li>Support regular customer quality reviews and maintain strong working relationships with key customer contacts.</li><li>Initiate internal technical quality improvement initiatives based on customer feedback, field failure data, and risk analysis.</li><li>Strengthen decision-making by identifying the most pragmatic solutions through cross-functional analysis of design, process, and supplier factors.</li></ul> Engineering &amp; Product Quality Assurance: <ul><li>Maintain strong product knowledge covering design intent, materials, machining, assembly, and related manufacturing processes.</li><li>Act as technical authority during escalations, challenging design or process decisions based on field data, reliability risk, and customer impact.</li><li>Support failure analysis and laboratory activities; convert findings into concrete design, process, or control improvements.</li><li>Serve as the link between field failures and design robustness, ensuring lessons learned are embedded into future products and updates.</li></ul> New Product Introduction &amp; Change Management: <ul><li>Participate in NPI and engineering change control processes to ensure customer quality, CTQ, and Copy Exact compliance.</li><li>Ensure customized or newly developed products fully meet customer specifications, quality standards, and regulatory requirements.</li><li>Provide engineering inputs for design reviews, DFMEA/DFMA, and quality guidelines from a customer and field reliability perspective.</li></ul> Culture &amp; Way of Working: <ul><li>Embody and promote company values: Integrity, Teamwork, Customer Centricity, and Innovation.</li><li>Foster a preventive mindset and risk-based thinking across engineering and quality activities.</li><li>Engage cross-functional teams with a clear focus on long-term product excellence and customer success.</li></ul> Requirements: <ul><li>Bachelor’s degree in mechanical, Mechatronics, Manufacturing Engineering, or related field.</li><li>5–10+ years’ experience in customer quality, product engineering, or industrialization within high-mix, precision manufacturing (semiconductor equipment preferred).</li><li>Strong ability to read and interpret drawings, GD&amp;T, simulations, specifications, and tolerance concepts.</li><li>Hands-on experience with 8D, 5 Whys, Ishikawa, DFMEA/PFMEA, DFMA, SPC, MSA, DOE.</li><li>Strong analytical, system-level, and reliability-focused thinking.</li><li>Ability to challenge technical decisions fact-based and constructively.</li><li>Strong communication skills in English, including customer-facing and executive-level discussions.</li><li>Strong command of English for global-level communication. Proficiency in Mandarin Chinese (for Chinese customer interaction) and Malay (for shop-floor communication) is highly advantageous.</li></ul>

Role Description: <ul><li>The Site Quality Leader is responsible for the administration, supervision, and development of the Wilsonville Quality Assurance and Quality Engineering functions.&nbsp;</li><li>This position is responsible for ensuring full compliance to the regulatory requirements of 21 CFR 820, ISO13485, MDR and other applicable regulations including production and process controls.&nbsp;</li><li>The Site Quality Leader will report to the Global Head of Quality Operations.</li></ul> Responsibilities: <ul><li>Ensure that Material Review Boards are in place to ensure products are appropriately dispositioned within a timely manner, while ensuring appropriate corrective and preventive actions are initiated and regulatory requirements are met.</li></ul>&nbsp;Develop and implement systems to assure that development as well as production teams receive support in the following areas: <ul><li>Quality planning, including inspection techniques and sampling methods</li><li>Statistical Analysis</li><li>Application of required regulatory standards</li></ul> Develop and implement procedures and systems to assure product manufactured for human use meets design and functional specifications. These systems are to include as a minimum: <ul><li>Delivery of raw materials and components</li><li>Manufactured devices and equipment</li><li>Documentation associated with these functions</li><li>Develop, track, and report on the following administrative systems:</li><li>Department metrics</li><li>Department objectives</li><li>Personnel development and training</li><li>Support regulatory agency and customer quality audits.</li><li>Ensure the conformity of the components and products are appropriately checked in accordance with the Quality Management System before release.</li><li>Responsible for assisting and training associates in concepts of probability and statistics.</li><li>Responsible for failure appraisal and analysis (internal and external).</li><li>Authority to place products or processes on hold.</li><li>Design and develop forms and instructions for recording, evaluating, and reporting quality data.</li><li>Corrective and Preventive Action program</li><li>Based on operational/quality requirements, assist in test equipment selection and validation.</li><li>Utilize formal problem solving techniques to resolve product and/or process related issues.</li><li>As required, lead cross-functional teams to support resolution of product and/or process related issues or objectives.</li><li>Work with suppliers of both raw materials and components, to improve product quality and/or resolve quality issues.</li><li>Be innovative, knowledgeable and intensely committed to ensure that every product and service we supply conforms to FDA and Quality System Regulations..</li></ul> Requirements: <ul><li>Bachelors Degree with a scientific or engineering emphasis.</li><li>ASQ Certified Quality Engineer recommended. Six Sigma Green/Black belt recommended.</li><li>7-10 years experience in a related regulatory environment.</li><li>Experience should include positions at senior levels within the medical device organizations.</li></ul>

Responsibilities: <ul><li>Understand business cycles and talent needs to develop and strengthen workforce capabilities aligned with business objectives.</li><li>Support recruiting and staffing initiatives and guide managers on compensation decisions.</li><li>Manage Family and Medical Leave Act (FMLA) and leave benefits through external program providers.</li><li>Facilitate and develop HR-related training and resources for managers to strengthen leadership and people management capabilities.</li><li>Support compensation and benefits administration, payroll, and salary management activities.</li><li>Align HR priorities with business unit strategies while balancing broader HR functional goals.</li><li>Maintain a positive and productive employee relations environment.</li><li>Drive a culture of continuous improvement and operational excellence.</li><li>Act as a change agent to support transformation initiatives, learning, and development programs.</li><li>Support employee engagement, culture initiatives, and inclusion &amp; diversity programs.</li><li>Partner with value stream managers and supervisors to develop employee training programs.</li><li>Ensure effective onboarding, orientation, and employee assimilation processes.</li></ul> Requirements: <ul><li>Bachelor’s degree in Human Resources or related field.</li><li>3–5+ years of experience as an HR Generalist within a manufacturing environment.</li><li>Prior plant/manufacturing site HR experience preferred with expertise in Employee Relations, Talent Acquisition, Coaching, and Development.</li><li>Experience working within cross-functional teams and influencing stakeholders.</li><li>Ability to manage ambiguity, risk, and shifting priorities.</li><li>Strong understanding of employment laws and HR best practices.</li><li>Proven experience in HR Operations, Compensation &amp; Benefits, Talent Management, Employee Relations, and Labor Relations.</li><li>Continuous improvement mindset with strong operational execution.</li><li>Strong strategic thinking and hands-on execution capabilities.</li><li>Excellent communication, facilitation, and presentation skills.</li><li>Ability to build trust and credibility across all organizational levels.</li><li>Strong interpersonal, organizational, analytical, and process-oriented skills with a strong sense of urgency.</li></ul>

Role Description: <ul><li>Quality Control (QC) Officer with hands-on experience in analytical testing and laboratory operations within API, pharmaceutical, or chemical manufacturing industries.</li><li>The candidate should have strong exposure to HPLC and other analytical instruments along with knowledge of GMP/GLP documentation and quality systems.</li></ul> Responsibilities: <ul><li>Perform analysis of raw materials, in-process samples, and finished products as per specifications and SOPs.</li><li>Handle and operate analytical instruments such as: o	High-Performance Liquid Chromatography (HPLC) o	GC o	UV Spectrophotometer o	FTIR o	Karl Fischer</li><li>Conduct wet chemical analysis, titration, LOD, moisture analysis, and related QC activities.</li><li>Prepare mobile phase, standard solutions, reagents, and test samples for analysis.</li><li>Perform calibration and routine maintenance of laboratory instruments.</li><li>Maintain laboratory records, logbooks, COA documentation, and reports as per GMP/GLP guidelines.</li><li>Follow SOPs, safety standards, and quality compliance procedures.</li><li>Support audit activities and maintain data integrity.</li><li>Coordinate with QA and Production teams for quality-related activities.</li></ul> Requirements: <ul><li>Strong hands-on experience in HPLC analysis (Mandatory)</li><li>Knowledge of GC, UV, FTIR, and wet chemistry.</li><li>Understanding of GMP, GLP, SOPs, and documentation practices</li><li>Good analytical and troubleshooting skills.</li><li>Ability to work in rotational shifts and plant environment Preferred Candidate Profile</li><li>Experience in API / Pharmaceutical / Chemical manufacturing industry</li><li>Good exposure to QC laboratory operations</li><li>Strong attention to detail and documentation accuracy</li></ul>

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159 electronic laboratory notebooks Jobs found

Scientist I, Quality Control LTS

Data Analyst

TA Specialist

Tool Room Engineer

Manufacturing Engineer

Strategic Sourcing III – Indirect Procurement

Development Engineer (Product Quality)

Site Quality Leader

HR PARTNER II

QC Officer

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Skills

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Jobtitle

159 electronic laboratory notebooks Jobs found

Scientist I, Quality Control LTS

Data Analyst

TA Specialist

Tool Room Engineer

Manufacturing Engineer

Strategic Sourcing III – Indirect Procurement

Development Engineer (Product Quality)

Site Quality Leader

HR PARTNER II

QC Officer

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

EMPLOYER

TALENT

COMPANY

Contact Us

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