Sr. QC Chemistry Associate I
About The Position
The Sr. QC Chemistry Associate I performs complex analytical testing, data review, and data analysis for in-process, release, stability, and raw material samples involving proteins, peptides, and small molecules. Working with minimal supervision, this role serves as a technical contributor and resource within the team, applying strong knowledge of QC chemistry practices, regulatory compliance, and laboratory workflows. The position independently supports method transfers, qualifications, validations, and troubleshooting, and may mentor junior staff. It ensures compliance with GMP/GLP requirements and contributes to improvements in quality and efficiency. The role also supports documentation and procedural development, investigates quality events, helps maintain laboratory equipment, and represents QC in cross-functional or client-facing meetings as needed. Regular and reliable full-time attendance is required.
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.
- Comfort providing technical guidance and training to junior team members.
- Proficiency in Microsoft Office applications.
- Strong attention to detail and written and verbal communication skills.
- Ability to work independently and collaboratively in a fast-paced environment.
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, providing 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 on 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
