Sr. QC Chemistry Associate I

Responsibilities

• Perform complex analytical testing for in-process, release, stability, and raw material samples for proteins, peptides, and small molecules.
• Demonstrate proficiency in compendial and non-compendial methods including HPLC, cIEF, USP Identification, UV-VIS, and Karl Fischer.
• Lead troubleshooting efforts for assays and identify process improvements to optimize testing efficiency.
• Author and review data packages, SOPs, test methods, and client-specific protocols in compliance with cGMP.
• Participate in method qualifications, validations, and transfers, including drafting technical protocols and reports.
• Mentor and train junior QC staff on analytical techniques and documentation practices.
• Investigate and document quality events, including deviations and out-of-specification (OOS) results using root cause analysis.
• Oversee laboratory equipment maintenance and ensure compliance with calibration schedules.

Requirements

• High School Diploma required; Bachelor’s degree in Life Sciences 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.
• Proficiency in troubleshooting instrumentation and assay issues.
• Strong written and verbal communication skills with high attention to detail.
• Ability to work independently and collaboratively in a fast-paced environment.

Preferred Qualifications

• Experience working with LIMS and QMS systems.
• Proficiency in Microsoft Office applications.

Benefits

• Competitive hourly rate with eligibility for an annual performance bonus.
• Paid time off.
• Health insurance coverage, including dental and vision.
• Flexible spending account.
• 401(k) retirement plan.

About the Company

PCI Pharma Services is a global provider of pharmaceutical services, acting as a bridge between life-changing therapies and the patients who need them. We invest in people who drive progress and create a better tomorrow through quality, operational excellence, and a culture of purposeful work.