QC Analytical Specialist

Job Description

BioPhase Solutions specializes in recruiting top talented professionals for Southern California's Scientific community. We are currently looking for a QC Analytical Specialist to work for a leading Greater Los Angeles area biotechnology company.

Pay Rate: $44-50/hour depending on experience.

Contract: 4-6+ months

Hybrid, Mon-Fri, Schedule flexible with manager approval

Summary:

The QC Analytical Specialist will serve as a Subject Matter Expert to advise contract testing laboratories on method development, method validation, method transfer, and quality investigations. Primary duties will include data review and troubleshooting of analytical test methods.

Responsibilities:

Author, review and revise documentation (SOPs, test methods, analytical method development, method validation, method transfer protocols/ reports, product specifications)

Review QC stability and lot release data (data integrity check) and CoAs issued by contract testing laboratories and create batch release certificate of analysis

Author and review laboratory OOS investigation and invalid laboratory test result, including filing internal Quality Systems reports as applicable

Author, review and revise Analytical Section of documents such as the IND, BLA for regulatory CMC submission

Provide technical expertise to troubleshoot analytical methods

Mange suppliers change notifications and change controls

Generate Purchase Requests and Purchase Orders for contract testing laboratories projects

Ensure timely escalation of quality control related issues

Assist QC-Analytical management in tracking and trending data

Collaborate with other departments (e.g. QA and Regulatory) for quality control related duties

Attend QC-Analytical internal meetings and external meetings with contract testing laboratories

May conduct other duties, as assigned

Experience/Requirements:

Bachelors with 8+ years or Masters with 6+ years of relevant experience in Analytical Chemistry or related discipline required

Experience in method development, method validation, method transfer, lot release tests, stability programs and specification development required

Strong knowledge of quality control analytical method development, method validation and method transfer

Strong technical writing skills to author SOPs, analytical tests methods, qualification/validation protocols/reports

Knowledge and understanding of USP, EP and ICH guidelines

In-depth knowledge of GMPs and pharmaceutical regulations

Ability to communicate effectively with internal functions both in writing and verbally

Ability to collaborate with contract testing laboratories, consultants, ensuring compliance with company procedures

Please send resumes to and visit our website at for additional job opportunities!

Full-time

Hybrid remote