Summary:The Sr. QC Chemistry Associate I performs complex testing, data review and data analysis for in-process, release, and stability assays of proteins, peptides, and small molecules. Operating with minimal supervision, this role serves as a technical contributor and resource within the team, demonstrating a strong understanding of QC chemistry practices, regulatory compliance, and laboratory workflows. The Sr. Associate I independently supports method transfers, qualifications, and troubleshooting efforts, and may assist in mentoring junior staff. This position ensures adherence to GMP/GLP requirements and contributes to ongoing improvements in quality and efficiency.
Essential Duties and Responsibilities: To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The essential duties and responsibilities include the following but other duties may be assigned.
- Independently performs routine and complex analytical testing for in-process, release, stability, and raw material samples, and provides technical guidance to team members as needed.
- Demonstrates strong proficiency in compendial and non-compendial methods such as USP Identification, AQL inspection, UV-VIS, SoloVPE, viscosity, Karl Fischer, and chromatography (e.g., HPLC, cIEF), ensuring accuracy and compliance.
- Leads troubleshooting efforts for assays and identifies process improvements to optimize testing efficiency and reliability.
- Authors and reviews data packages, ensuring adherence to cGMP, SOPs, and regulatory expectations.
- Writes, revises, and implements test methods, SOPs, and client-specific protocols, contributing to procedural development and standardization.
- Participates in and may lead method qualifications, validations, and transfers, including drafting of technical protocols and reports.
- Mentors and trains junior QC staff on analytical techniques, documentation practices, and laboratory operations. Investigates and documents quality events, including deviations and out-of-specification (OOS) results, with a clear understanding of root cause analysis and CAPA.
- Act as a QC representative in cross-functional or client-facing meetings as needed.
- Oversees maintenance and proper use of laboratory equipment and ensures compliance with calibration schedules and procedures.
- Proactively contributes to continuous improvement initiatives and department goals.
- Regular and reliable attendance on a full-time basis [or in accordance with posted schedule].
Qualifications: The requirements listed below are representative of the knowledge, skill, and/or ability required for the stated position. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions.
- High School Diploma required. Bachelor's degree in Life Sciences discipline or equivalent is strongly preferred.
- Minimum of six (6) 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.
- Experience with LIMS and QMS systems preferred.
- Proficiency in troubleshooting instrumentation and assay issues.
- Comfortable providing technical guidance and training to junior team members.
- Proficiency in Microsoft Office applications.
- Detail-oriented with strong written and verbal communication skills.
- Able to work independently and collaboratively in a fast-paced environment.
The hiring rate for this position is $36.54 - 41.10 plus eligibility for an annual performance bonus. Final offer amounts are determined by multiple factors, including but not limited to specific and relevant experience, education, credentials, geography, and subject matter expertise. PCI offers full-time employees a competitive benefits package that includes paid time off, health insurance coverage (including dental and vision), a flexible spending account, and a 401(k) plan.
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