QC Lab Sample Coordinator

QE Specialist

Senior Electrical Engineer

QC Chemist

Microbiology Technician

Central Demand Planner

Test

Senior QA Automation Engineer

Sr. Analyst – Enterprise Systems

Technical Product Manager

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>Provide real-time QA oversight on the production floor, in warehouse areas, and during qualification activities.</li><li>Perform batch record and logbook review, ensuring accuracy, completeness, and compliance with GDP standards.</li><li>Execute and document line clearance and room readiness inspections prior to manufacturing activities.</li><li>Review qualification and validation protocols for clarity, compliance, and alignment with regulatory and internal quality expectations.</li><li>Support execution of qualification protocols by providing on-site quality presence during testing and ensuring deviations are properly documented and escalated. 6.	Initiate, investigate, and support closure of deviations, non-conformances, and CAPAs related to manufacturing and qualification activities.</li><li>Collaborate with cross-functional teams to ensure timely and compliant execution of commissioning, qualification, and validation activities.</li><li>Support the development and maintenance of site-specific quality procedures (SOPs, work instructions, forms) governing manufacturing, warehousing, engineering, maintenance, and validation operations.</li><li>Review and approve site procedures to ensure clarity and compliance with cGMP standards.</li><li>Maintain awareness of site policies, cGMP regulations, and evolving regulatory expectations applicable to sterile injectable operations.</li><li>Participate in internal walkthroughs, audit preparations, and readiness activities for regulatory inspections.</li><li>Support the implementation of continuous improvement initiatives and site quality metrics.</li></ul> Requirements: Qualifications/Experience <ul><li>Bachelor’s degree in a scientific, engineering, or technical discipline (e.g., Biology, Chemistry, Pharmacy, Engineering)</li><li>2–5 years of experience in quality assurance, manufacturing, or validation in a cGMP-regulated pharmaceutical or biotech manufacturing environment</li><li>Working knowledge of FDA, EU, and ICH guidelines related to sterile manufacturing, validation, and data integrity</li><li>Experience supporting commissioning and qualification activities is strongly preferred</li><li>Familiarity with GDP, batch record review, and deviation documentation processes</li></ul> Skills/Competencies <ul><li>Strong attention to detail and commitment to compliance</li><li>Solid written and verbal communication skills</li><li>Ability to work collaboratively across departments in a fast-paced environment</li><li>Comfortable supporting shop-floor activities and cross-functional execution teams</li><li>Proficient in using quality systems and document management tools</li><li>Flexible and adaptable to changing priorities and evolving project timelines</li><li>Commitment to data integrity, continuous improvement, and patient safety</li></ul>

Responsibilities: <ul><li>Meeting with the product engineers to determine product testing parameters.</li><li>Conducting quality assurance and designing performance tests using the new testing procedures.</li><li>Troubleshooting any errors and streamlining the testing procedures. Ensuring all tests and procedures meet company and industry standards.</li><li>Preparing test reports for management.</li></ul> Requirements: <ul><li>BS Degree in Engineering or Science, 5+ years’ experience related to primary job function, Electrical Engineering preferred.</li><li>Experience with software such as Altium, Ultiboard, Multisim, AutoCAD, Space Claim, Creo, and LabVIEW desirable.</li><li>Experience with solid state power switching highly desirable.</li><li>Familiarity with 270Vdc and 1000Vdc applications desirable.</li><li>Effective communication and presentation skills required.</li><li>Ability to maintain focus and complete tasks independently and on time.</li><li>This position requires access to information which is subject to stringent controls under the International Traffic in Arms Regulations (ITAR) or Export Administration Regulations (EAR). Candidates must be a U.S. citizen or national, U.S. lawful permanent resident, person granted asylee status in the U.S., or person admitted into the U.S. as a refugee.</li></ul>

Role Description: <ul><li>The QC Chemist will be a critical member of the laboratory team responsible for performing analytical testing to ensure the quality, safety, and compliance of sterile injectable IV bag products at a newly established greenfield pharmaceutical manufacturing facility.</li><li>This role will support the development, validation, and execution of analytical methods, ensure timely release of raw materials, in-process samples, and finished products, and maintain strict adherence to cGMP, FDA, and global regulatory standards.</li><li>The QC Chemist will play a key role in establishing laboratory operations during the startup phase and sustaining high standards of laboratory excellence throughout routine commercial production.</li></ul> Responsibilities: <ul><li>Perform analytical testing of raw materials, in-process samples, stability samples, and finished products using validated methods (e.g., HPLC, GC, UV-Vis, FTIR, TOC, etc.).</li><li>Develop and validate new analytical methods as required to support product development, regulatory submissions, and process optimization.</li><li>Ensure compliance with cGMP, FDA, USP, and other regulatory standards in all laboratory activities, documentation, and data integrity.</li><li>Prepare and review laboratory documentation including test protocols, reports, COAs, deviations, OOS investigations, and change control documentation.</li><li>Maintain laboratory instruments, perform routine calibrations, troubleshooting, and coordinate with vendors for preventive maintenance and repairs.</li><li>Support laboratory readiness for regulatory inspections, audits, and customer visits by maintaining audit-ready documentation and laboratory practices.</li><li>Assist in the preparation and execution of laboratory investigations, CAPA implementation, and root cause analysis for any analytical deviations.</li><li>Collaborate with cross-functional teams including Manufacturing, Quality Assurance, Validation, and Regulatory Affairs to ensure seamless batch release and product compliance.</li><li>Participate in training programs to ensure technical competency and adherence to evolving regulatory requirements.</li><li>Contribute to continuous improvement initiatives focused on laboratory efficiency, data integrity, and compliance robustness.</li></ul> Requirements: Qualifications/Experience: <ul><li>Bachelor’s or master’s degree in chemistry, Pharmaceutical Sciences, or related field.</li><li>3+ years of experience in pharmaceutical QC laboratory, preferably in sterile injectable manufacturing.</li><li>Strong hands-on experience with analytical instrumentation (HPLC, GC, UV, FTIR, etc.) and GMP-compliant laboratory operations.</li><li>Knowledge of FDA cGMP regulations, USP standards, ICH guidelines, and data integrity expectations.</li><li>Experience supporting laboratory investigations and regulatory inspections.</li></ul> Skills/Competencies: <ul><li>Strong analytical and problem-solving skills.</li><li>High attention to detail and accuracy in laboratory work.</li><li>Good understanding of data integrity and documentation practices.</li><li>Ability to work both independently and as part of a team in a dynamic startup environment.</li><li>Excellent organizational, time management, and communication skills.</li><li>Ability to adapt to evolving processes and regulatory requirements in a greenfield manufacturing setting.</li></ul>

Responsibilities: <ul><li>Perform routine environmental monitoring (viable and non-viable) in classified cleanroom areas (Grade A/B/C/D), including surface and personnel monitoring. Manufacturing is performed inside isolators with surrounding grade C environment.</li><li>Collect and test samples from water systems (e.g., purified water, WFI), compressed gases, and other utilities per GMP and site procedures.</li><li>Support aseptic process simulations (media fills), including preparation, execution, and recovery/interpretation of microbiological data.</li><li>Perform microbiological tests such as bioburden, endotoxin (LAL), and sterility testing for raw materials, in-process samples, and finished products.</li><li>Prepare microbiological media, perform growth promotion testing, and maintain inventory of reagents and supplies.</li><li>Maintain laboratory notebooks, logs, and electronic systems in a compliant and organized manner, ensuring adherence to data integrity standards.</li><li>Support qualification and validation activities including cleanroom and utility qualifications, method validations, and EM qualification mapping.</li><li>Assist in investigations related to microbial excursions or deviations and contribute to the development and implementation of CAPAs.</li><li>Support microbiology lab startup activities including equipment qualification, SOP development, and execution of technical transfer protocols.</li><li>Follow all safety, quality, and regulatory policies, and maintain compliance with cGMP, USP, EU Annex 1, and other applicable guidelines.</li></ul> Requirements: Qualifications/Experience: <ul><li>Associate’s or bachelor’s degree in microbiology, Biology, Life Sciences, or a related field.</li><li>1–3 years of microbiology laboratory experience in a GMP-regulated pharmaceutical or biotechnology manufacturing environment.</li><li>Experience working in sterile environments or supporting aseptic processes preferred.</li><li>Familiarity with environmental monitoring equipment (e.g., particle counters, air samplers), microbiological techniques, and lab instrumentation.</li><li>Knowledge of cGMPs, data integrity principles, and microbiological standards (USP &lt;61&gt;, &lt;62&gt;, &lt;71&gt;, &lt;85&gt;, &lt;1116&gt;).</li></ul> Skills/Competencies: <ul><li>Strong attention to detail and commitment to data accuracy and integrity.</li><li>Ability to work independently while collaborating effectively within a team</li><li>Good time management and organizational skills to support multiple tasks and priorities.</li><li>Proficient in the use of Microsoft Office and basic laboratory software systems.</li><li>Willingness to work flexible shifts or weekends to support aseptic operations and testing schedules, as needed.</li><li>A proactive and patient-focused mindset with a strong sense of ownership and compliance.</li></ul>

Responsibilities: <ul><li>Lead the Global Demand Planning Cycle of the S&amp;OP process: Own and execute the monthly demand process from system handover to consensus sign-off. </li><li>Coordinate inputs from Sales, Product Management, and Finance, and ensure outputs feed into supply planning and S&amp;OP.</li></ul> Improve Forecast Accuracy:&nbsp; <ul><li>Drive measurable improvements in MAPE, Bias, and Forecast Adherence. Use data-driven techniques and root-cause analysis to understand gaps and implement corrective actions.</li></ul> Bridge Strategy and Execution:&nbsp; <ul><li>Translate commercial assumptions and market intelligence into an aligned, actionable forecast that drives capacity, procurement, and financial planning.</li></ul> Advance Tools and Reporting:&nbsp; <ul><li>Develop and maintain robust forecasting reports and KPIs using Excel, Power BI (or Tableau), and SAP IBP. </li><li>Push the team toward automated, visual, and insightful reporting.</li><li>Facilitate Consensus and Governance: Orchestrate monthly consensus meetings and prepare executive-ready materials that clearly communicate changes, assumptions, and risks.</li></ul> Support Constrained Planning:&nbsp; <ul><li>Collaborate with the Supply Planner to identify constraint-driven adjustments and simulate scenarios to evaluate trade-offs.</li><li>Enhance Collaboration and Accountability: Act as the single point of contact for demand planning across regions. Push for timely inputs, challenge assumptions, and ensure cross-functional accountability.</li></ul> Lead Process Improvements:&nbsp; <ul><li>Identify inefficiencies and design solutions—whether it’s template optimization, system enhancements, or training stakeholders on best practices.</li></ul> Support S&amp;OP Strategy:&nbsp; <ul><li>Contribute actively to the broader S&amp;OP cycle, including confidence-level strategies, forecast version control, and long-range planning exercises.</li></ul> Requirements: <ul><li>Bachelor’s degree in supply chain, Engineering, Business, or related field; Master’s preferred</li><li>Minimum 5 years of experience in demand planning or S&amp;OP in a multinational environment</li><li>Demonstrated ability to work independently and proactively influence cross-functional teams</li><li>High proficiency in Excel and Power BI (or Tableau); experience with SAP IBP is strongly preferred</li><li>Strong business acumen and communication skills; able to translate data into decisions</li><li>Fluent in English</li></ul>

Responsibilities: <ul><li>Together with the team of developers handle the product quality.</li><li>Lead and manage the automation testing efforts and deliverables.</li><li>Plan and prioritize testing activities.</li><li>Maintain and improve an existing test automation framework.</li><li>Develop automation tests for API and UI.</li><li>Execute, maintain and update automation tests.</li><li>Review and analyze tests execution results.</li><li>Maintain all related test documentation.</li><li>Prepare testing data.</li><li>Proactively acquire and clarify requirements as necessary.</li><li>Mentor less skilled teammates and newcomers.</li></ul> Requirements: <ul><li>Strong knowledge of OOP (understanding OOP in automation).</li><li>Excellent knowledge of automation testing principles.</li><li>Excellent knowledge of web-based application structure.</li><li>Excellent knowledge of Python programming language.</li><li>Expert in REST API testing.</li><li>Experience in UI testing.</li><li>Wide experience in developing automation testing frameworks.</li></ul>

Responsibilities: <ul><li>Configure, implement, enhance, support, and test applications supporting global SAP Finance functions.</li><li>Develop and improve a new global SAP S4 template, with a rollout planned over the next 3–5 years.</li><li>Participate in SAP implementation projects, focusing on Finance and Controlling areas and integration points with logistics modules (SD/MM/PP).</li><li>Prepare and execute master data and transactional data migration activities.</li><li>Define Finance data standards and governance rules.</li><li>Provide training to business and project teams as required.</li><li>Identify, evaluate, and implement opportunities to improve systems and procedures, including documenting business requirements, designing, and implementing solutions.</li><li>Prepare development specifications and collaborate with technical experts to design and test new programs or changes to existing programs. Serve as a project lead on SAP projects as required.</li><li>Work closely with all levels of staff within shared service finance and Business Unit (BU) controlling organizations.</li><li>Collaborate with the external AMS provider to continuously improve services for our client SAP ECC platforms and S4 system.</li></ul> Requirements: <ul><li>Bachelor’s degree in Computer Science, Information Systems, Business Administration with a Finance concentration, or equivalent experience.</li><li>Experience in SAP S4 with a complete project cycle.</li><li>Experience in SAP ECC Finance and Controlling.</li><li>Ability to work independently while meeting shifting deadlines.</li><li>Strong interpersonal skills to interact with staff and management at various levels.</li><li>Ability to understand and translate business needs into technical solutions.</li><li>Project management skills.</li><li>Strong analytical skills to investigate user issues and provide resolutions.</li><li>Ability to adapt to changing user requirements and business environments.</li></ul>

Responsibilities: <ul><li>Collaborate with stakeholders to define product requirements and roadmap.</li><li>Translate customer needs into clear and actionable technical specifications.</li><li>Write and refine business requirements and acceptance criteria.</li><li>Work closely with product managers to prioritize the backlog in JIRA.</li><li>Work closely with engineering teams to ensure successful and timely product development and delivery.</li><li>Act as the primary liaison between business stakeholders, clients, and technical teams.</li><li>Run cross-functional meetings and facilitate decision-making.</li><li>Provide transparency on product status, risks, and dependencies.</li><li>Review and test deliverables to ensure they meet business requirements.</li></ul> Requirements: <ul><li>Strong technical background with knowledge of blockchain technology and distributed systems.</li><li>Experience with Agile/Scrum methodologies and product management tools such as JIRA.</li><li>Excellent problem-solving and analytical skills.</li><li>Strong communication and leadership abilities.</li><li>Strong organizational and facilitation skills.</li><li>Ability to work effectively in a fast-paced, dynamic environment.</li><li>Collaborative team player with the ability to influence without authority.</li></ul>

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49 test scenarios Jobs found

QC Lab Sample Coordinator

QE Specialist

Senior Electrical Engineer

QC Chemist

Microbiology Technician

Central Demand Planner

Test

Senior QA Automation Engineer

Sr. Analyst – Enterprise Systems

Technical Product Manager

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Skills

Industry

Location

Jobtitle

49 test scenarios Jobs found

QC Lab Sample Coordinator

QE Specialist

Senior Electrical Engineer

QC Chemist

Microbiology Technician

Central Demand Planner

Test

Senior QA Automation Engineer

Sr. Analyst – Enterprise Systems

Technical Product Manager

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

EMPLOYER

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COMPANY

Contact Us

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