Quality Control Specialist

4 days ago

Marlborough, Massachusetts, United States Randstad Full time
Job Summary:

As a leading staffing and recruitment agency, Randstad is committed to finding talented professionals like you the perfect role in the life sciences arena. With a vast network of top employers and detailed information about hundreds of positions, we can help you learn and grow in a dynamic environment. Our current partnership with a company renowned for its innovative clinical trials and Research & Development initiatives offers a unique opportunity to make a meaningful impact. Apply now to join a team that values collaboration, innovation, and excellence.

Responsibilities:
  • Execute and troubleshoot laboratory test methods, defining requirements for procedure implementation and identifying continuous improvement initiatives.
  • Work closely with the assay transfer technical lead, mentor junior analysts, and develop training initiatives within the labs.
  • Develop and revise technical reports, laboratory procedures, and LIMS builds, execute and troubleshoot release, stability, and in-process testing, and design and perform testing in support of method transfer/validation/qualification/verification.
  • Review and authorize data, perform analysis and interpretation of test results and trends, and design and/or participate in method development, equipment qualification/validation studies, deviation, and OOS investigations.
  • Perform QC lab support activities, including sample management, reagent preparation, instrumentation maintenance, and instrument calibration, and support and mentor junior team members.
  • Collaborate with other network sites to share best practices and perform other duties as required.
Qualifications:
  • Bachelor's degree in chemistry, biological sciences, or a related field with 6+ years of experience or a Master's degree with 4+ years of experience in a GMP Quality Control role.
  • Prior laboratory hands-on experience with various analytical techniques, including HPLC, CE, DLS, UV-VIS spectroscopy, sub-visible particulate analysis, pH, osmolality, and other chromatographic and physiochemical techniques.
  • Strong understanding of data integrity requirements and regulatory requirements pertaining to biotechnology and pharmaceutical industries, and proven experience analyzing experimental data.
  • Experience using LIMS as an end-user, excellent technical writing and verbal communication skills, and the ability to observe and adhere to lab safety standards and procedures.
  • Ability to work independently with minimal instructions, strong interpersonal skills, and a collaborative mindset within a multi-discipline team.
  • Strong knowledge of GMP, SOPs, and quality control processes, and the ability to excel in a fast-paced team environment, handle multiple tasks concurrently, and in a timely fashion.
Working Conditions:
  • This role frequently requires long periods of sitting, standing, and use of hands and regular motion to include bending, stooping, and lifting up to 20lbs.
  • This is an on-site role working in a cGMP regulated manufacturing facility, and occasional travel to other manufacturing facilities may be required.
Skills:
  • HPLC, SOP, GMP, LIMS

Randstad is an equal opportunity employer and welcomes people of all abilities. If you require a reasonable accommodation to make your application or interview experience a great one, please contact us. Pay offered to a successful candidate will be based on several factors, including education, work experience, work location, specific job duties, certifications, and more. We offer a comprehensive benefits package, including health, an incentive and recognition program, and 401K contribution (all benefits are based on eligibility).

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