QC Associate I - Contract
About The Position
The Quality Control (QC) Associate I is responsible for performing analytical testing and laboratory activities that support stability, qualification/validation, and release testing of biologics in a cGMP-regulated environment. This role supports routine QC operations through the execution of analytical methods, data review, equipment maintenance, QC inventory management, and continuous improvement initiatives while ensuring compliance with current Good Manufacturing Practices (cGMP), Good Documentation Practices (GDP), and applicable regulatory requirements. The successful candidate will demonstrate technical expertise, attention to detail, data integrity awareness, and a commitment to maintaining inspection readiness while supporting internal and client-driven programs.
Requirements
- Bachelor’s degree in biology, Biochemistry, Chemistry, Pharmaceutical Sciences, Biotechnology, or a related scientific discipline required.
- 0–2 years of laboratory experience in biotechnology, pharmaceutical, or related industries.
Responsibilities
- Perform routine and non-routine analytical testing of in-process, release, stability, raw material, and investigational samples using approved methods and procedures.
- Execute a variety of analytical techniques commonly used for biologics and large-molecule products, including but not limited to: CE-SDS, Endotoxin, Raw Material Testing, ELISA, UV-Vis Spectroscopy, Compendial testing, and other biochemical and physicochemical methods as applicable.
- Ensure all testing activities are completed accurately, efficiently, and within established timelines.
- Maintain laboratory notebooks, worksheets, logbooks, and electronic records in accordance with GDP and ALCOA+ data integrity principles.
- Ensure all activities comply with GMP, ALCOA+ principles, and data integrity regulations (FDA, EMA, ICH guidelines).
- Participate in lifecycle management activities including GMP document management, sample storage/inventory management, and materials ordering.
- Perform first-person review of analytical data to ensure completeness, accuracy, and compliance with applicable procedures and regulatory requirements.
- Ensure documentation is complete, contemporaneous, attributable, and inspection ready.
- Maintain laboratory equipment records and ensure equipment remains in a qualified state.
- Support laboratory readiness for internal audits, client audits, regulatory inspections, and quality assessments.
- Participate in process improvement initiatives to enhance laboratory efficiency, compliance, and data integrity.
- Collaborate effectively with cross-functional teams including QA, Manufacturing, and Materials Management.
- Support implementation of new technologies, systems, and laboratory processes readiness activities.
Benefits
- Inclusive and accessible workplace
- Reasonable accommodation available
- Equal opportunity employer
- Commitment to diversity and inclusion
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What This Job Offers
Job Type
Full-time
Career Level
Entry Level
