QC Chemistry Associate III - 2nd Shift

PCI Pharma Services•San Diego, CA

8d•Onsite

About The Position

This position is responsible for conducting routine analysis of in process, release and stability assays for proteins, peptides and small molecules under general supervision. The role may focus in a specialized area and provide routine analysis, data review, and testing according to standard operating procedures in any of the following areas: Sample testing and release development of assays and performing qualifications. Hours: 2nd Shift 2:00 PM -10:30 PM

Requirements

High School Diploma required.
Bachelor’s degree strongly preferred in a Life Sciences discipline or equivalent.
Minimum of four (4) years of relevant experience in a laboratory setting.
Experience with GMP, aseptic techniques, troubleshooting, and data entry.
Preferred experience in LIMS and QMS software.
Ability to perform testing in a highly accurate and reproducible manner.
Proficiency with Microsoft Office applications.
Detail oriented with strong written and verbal communication skills.
Ability to work independently, within prescribed guidelines, or as a team member.
Demonstrated ability to follow detailed directions in a laboratory environment.

Responsibilities

Independently conducts and reviews routine and complex analysis and testing of samples with minimal supervision, often specializing in a specific QC area while providing technical guidance to junior team members.
Independently performs release testing assays for in-process, final product, raw materials, stability, and other routine samples, demonstrating proficiency in compendial assays, USP Identification assays, AQL Inspection, UV-VIS, SoloVPE concentration assays, viscosity, Karl Fischer, and chromatography methods such as HPLC and cIEF.
Performs complex assays, including ELISA, plate-based assays, HPLC, LC-MS, and CE-SDS, with a strong ability to troubleshoot and optimize methods as needed.
Adheres to cGMP requirements and SOPs.
Compiles data for documentation of test procedures.
Reviews batch records and specifications as required.
Generation and collaborator Standard Operating Procedures (SOPs) for internal use and client specific methods.
Collaborates on and participates in the transfer, qualification and validation of new testing methods with guidance from supervisor, which may include writing protocols and reports
Trains junior personnel on quality control methods and SOPs.
Participate in Client Interface meetings as may be required or necessary.
Technical writing of investigations for deviations and Out of Specifications (OOSs)
Regular and reliable attendance on a full-time basis [or in accordance with posted schedule].
Responsible for exhibiting professional behavior with both internal and external business associates that reflects positively on the company and is consistent with the company’s policies and practices.
Embodies PCI Pharma’s cultural values and aligns daily actions with department goals and company culture.