Sr. QC Chemistry Associate I
About The Position
The Sr. QC Chemistry Associate I performs complex testing, data review, and data analysis for in-process, release, and stability assays involving proteins, peptides, and small molecules. With minimal supervision, this position serves as a technical contributor and resource for the team, applying knowledge of QC chemistry practices, regulatory compliance, and laboratory workflows. The role independently supports method transfers, qualifications, and troubleshooting, may mentor junior staff, and helps ensure compliance with GMP/GLP requirements while contributing to quality and efficiency improvements. The position performs analytical testing and data review, develops and revises methods and procedures, supports method qualifications, validations, and transfers, and investigates quality events. It also provides technical guidance and training, represents QC in cross-functional or client-facing discussions as needed, and oversees appropriate equipment use and maintenance. Regular and reliable full-time attendance is required, or attendance in accordance with the posted schedule.
Requirements
- High school diploma required.
- At least six years of relevant experience in a GMP-regulated laboratory setting.
- Strong working knowledge of GMP standards, aseptic techniques, and laboratory best practices.
- Demonstrated ability to perform complex analytical testing accurately and reproducibly.
- Proficiency in troubleshooting instrumentation and assay issues.
- Proficiency in Microsoft Office applications.
- Strong written and verbal communication skills and attention to detail.
- Ability to work independently and collaboratively in a fast-paced environment.
- Comfort providing technical guidance and training to junior team members.
Nice To Haves
- Bachelor’s degree in a life sciences discipline or equivalent.
- Experience with LIMS and QMS systems.
Responsibilities
- Independently perform routine and complex analytical testing for in-process, release, stability, and raw material samples, and provide technical guidance to team members as needed.
- Perform compendial and non-compendial testing, including USP Identification, AQL inspection, UV-VIS, SoloVPE, viscosity, Karl Fischer, and chromatography such as HPLC and cIEF.
- Lead assay troubleshooting and identify process improvements to optimize testing efficiency and reliability.
- Author and review data packages in accordance with cGMP, SOPs, and regulatory expectations.
- Write, revise, and implement test methods, SOPs, and client-specific protocols.
- Participate in and potentially lead method qualifications, validations, and transfers, including drafting technical protocols and reports.
- Mentor and train junior QC staff in analytical techniques, documentation practices, and laboratory operations.
- Investigate and document quality events, including deviations and out-of-specification results, using root cause analysis and CAPA practices.
- Represent QC in cross-functional or client-facing meetings as needed.
- Oversee laboratory equipment maintenance and proper use, and ensure compliance with calibration schedules and procedures.
- Contribute proactively to continuous improvement initiatives and department goals.
- Maintain regular and reliable full-time attendance, or attendance in accordance with the posted schedule.
Benefits
- Paid time off
- Health insurance coverage, including dental and vision
- Flexible spending account
- 401(k) plan
- Eligibility for an annual performance bonus
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What This Job Offers
Job Type
Full-time
Career Level
Senior
Education Level
High school or GED
