Sr. QC Chemistry Associate I

PCI TRGR Penn Pharmaceutical Services Ltd; San Diego (CA); On-site; USD 50,000 - 57,000; Full time

Benefits offered by this job

Health insurance (dental & vision)

Flexible spending account

401(k) plan

Job summary

PCI Pharma Services is seeking a Sr. QC Chemistry Associate I to perform complex analytical testing, data review and data analysis for in-process, release, and stability assays of proteins, peptides, and small molecules.

This role operates with minimal supervision and supports method transfers, qualifications, and troubleshooting while mentoring junior staff. The position requires strong GMP knowledge, aseptic technique proficiency, and experience with LIMS/QMS systems, plus the ability to lead

Qualifications

• High School Diploma required.
• Bachelor’s degree in Life Sciences strongly preferred.
• Minimum of six years of GMP-regulated laboratory experience.
• Strong working knowledge of GMP standards, aseptic techniques, and laboratory best practices.
• 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.

Responsibilities

• Perform routine and complex analytical testing for in-process, release, stability, and raw material samples.
• Provide technical guidance to team members as needed.
• Lead method qualifications, validations, and transfers, including drafting protocols and reports.
• Author and review data packages ensuring GMP compliance and SOP adherence.
• Mentor and train junior QC staff on analytical techniques and documentation.
• Investigate deviations and OOS with root cause analysis and CAPA.
• Represent QC in cross-functional or client meetings as needed.
• Oversee calibration and proper use of laboratory equipment.

Skills

GMP knowledge

Aseptic techniques

Analytical testing

Documentation

Training juniors

Education

High School Diploma

Bachelor’s degree in Life Sciences

Tools

LIMS

QMS

Job description

Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients. We are PCI. Our investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy includes building teams across our global network to pioneer and shape the future of PCI.

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

• 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

• 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.

#LI-AC1 Join us and be part of building the bridge between life changing therapies and patients. Let’s talk future

Equal Employment Opportunity (EEO) Statement

PCI Pharma Services is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status. At PCI, Equity and Inclusion are at the core of our company’s purpose: Together, delivering life-changing therapies. We are committed to cultivating an inclusive workplace by holding ourselves accountable to the highest standards of understanding, fairness, respect, and equal opportunity – at every level. We envision a PCI community where everyone can belong and grow, and we strive to bring this vision to reality by continuously and intentionally assessing our people practices, policies and programs, marketing approach, and workplace culture.

Why work for PCI Pharma Services? At PCI, we have an uncompromising focus on providing quality and operational excellence and providing the industry leading customer experience. Our people make all of this happen, so providing an industry leading experience for our people is equally as important. By creating an authentic culture of purposeful work, we aspire to be an interesting and fulfilling place for talented individuals to grow careers. We live a philosophy of intentional learning combined with real-life experience supported by a fair and competitive rewards program. We are individuals, teams and a company that believes in our purpose and our approach is simple, the people who work at PCI fuel our business; we don’t say no, we figure out how.