1532 QC Analyst 3
Job Summary:
The QC Analyst IV is a member of the Quality Control department responsible for supporting production of in-process and final product drug lots and for performing quality testing for ongoing customer stability studies.
This role delivers timely, high-quality results to meet manufacturing needs, applies company policies and procedures to a range of tasks of increased scope, and may support special projects or act in the supervisor’s absence.
Works on problems of moderate scope requiring review of identifiable factors.
Key Accountabilities:
Provide feedback and guidance to junior analysts on procedures, compliance, and daily tasks.
Delegate and coordinate tasks to support daily laboratory operations and workload balance.
Maintain laboratory equipment readiness by coordinating maintenance, calibration, and vendor activities; ensure equipment (e.g., pH/conductivity meters, Agilent/Waters HPLC and UPLC systems, pipettes, SoloVPE, Cary 60 spectrophotometers, PA-800, Protein Simple iCE3/icIEF, 7500 Real Time PCR, KingFisher Flex, Sysmex CS-2500) is appropriately serviced and documented.
Troubleshoot instrument and software issues and escalate to maintenance or vendors as required.
Train and perform assay execution and data review in the HPLC Analytical and Electrophoresis labs; cross-train into Immunology as needed.
Acquire and execute advanced assays as necessary to support laboratory needs.
Identify process and documentation improvements (e.g., 6S, SOP/document revisions, work orders, change controls) and assist with implementation.
Communicate with Manufacturing, QA, MSAT, and other departments during operations and escalate issues as needed.
Initiate and assist with investigations related to quality events, deviations, or non-conformances.
Drive audit readiness: perform pre-audit walkthroughs, act as a QC subject-matter expert during audits, and speak confidently to auditors.
Apply Data Integrity principles in all aspects of work in compliance with DI policies and guidelines.
Complete assigned tasks on time and accurately; proactively identify and execute necessary tasks without detailed direction.
Perform other duties as assigned.
Education:
Required: Bachelor’s degree in Biochemistry or a related scientific field.
Preferred: A combination of education and additional years of relevant experience may be considered.
Experience:
Required: Advanced level (5–10 years) industry experience, preferably in a cGMP environment.
Certifications:
None required; professional certifications are a plus.
Competencies & Behaviors Agility:
Willingness to take on new challenges and adapt thinking/behavior to support change.
Supports continuous process improvement and problem solving.
Business Acumen:
Proposes ideas to improve business area and interprets data effectively.
Comfortable speaking publicly and making basic quality decisions independently.
Collaboration:
Works as an active team member, values different perspectives, shares knowledge, and treats coworkers with respect.
Customer Focus:
Understands internal and external customer needs and delivers accordingly.
Driving Results:
Ensures quality standards are maintained, consistently delivers goals while monitoring KPIs.
Plans, prioritizes, and organizes work effectively.
Leadership:
Demonstrates safety responsibility and professionalism; acts as an example to other analysts.
Quality:
Must adhere to cGMPs at all times. All personnel are responsible for timely reporting of regulatory inspections, serious GMP deficiencies, process deviations, product defects, and related actions.
Safety:
Must follow job safety procedures, attend required health and safety training, proactively promote safety, and promptly report incidents. Must comply with site safety policies.
Skills & Technical Requirements:
Ability to comprehend and follow written and verbal instructions.
Exercise judgment within defined procedures to determine appropriate action.
Strong data interpretation skills, independently and with guidance.
Punctual and able to work full assigned shifts.
Strong written and verbal communication skills.
Self-motivated team player with a positive and professional attitude.
Complete assignments on time and accurately with minimal rework.
Commitment to quality and performance excellence.
Ability to perform complex and varied tasks, prioritize work, solve problems, and plan/coordinate tasks and projects.
Facilitate brainstorming and continuous improvement initiatives.
Data Integrity & Regulatory Expectations:
Apply Data Integrity principles in all tasks and maintain audit-ready documentation.
Participate in pre-audit walkthroughs and support audits as QC SME.
Working Conditions:
Laboratory environment with standard PPE and safety protocols. May require standing for extended periods and handling of laboratory instruments and materials.
Application Instructions:
Submit resume and cover letter demonstrating experience in cGMP laboratory testing, instrument operation (list relevant systems), and examples of cross-training, troubleshooting, or audit support.
The hiring rate for this position is $58 to $63.97/hr per hour. The base pay actually offered will take into account internal equity, and may also vary depending on candidate’s geographic region, job-related knowledge, skills, and experience amongst other factors.
Harvest Technical Services is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, Sexual orientation, national origin, genetics, pregnancy, disability, age, veteran status, or any other federal, state, or local protected class.