Senior QC Chemistry Analyst - GMP, Method Transfers

PCI TRGR Penn Pharmaceutical Services Ltd; San Diego (CA); Sur place; USD 50 000 - 57 000; Plein temps

Avantages offerts par ce poste

Health insurance (dental & vision)

Flexible spending account

401(k) plan

Résumé du poste

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.

Responsabilités

• 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.

Connaissances

GMP knowledge

Aseptic techniques

Analytical testing

Documentation

Training juniors

Formation

High School Diploma

Bachelor’s degree in Life Sciences

Outils

LIMS

QMS

Description du poste

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