Job Description
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 : $44-49 / hour depending on experience.
Contract : 4-6+ months
On-Site with occasional remote work, Mon-Fri, (8am-5pm - 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 requiredExperience in method development, method validation, method transfer, lot release tests, stability programs and specification development requiredStrong knowledge of quality control analytical method development, method validation and method transferStrong technical writing skills to author SOPs, analytical tests methods, qualification / validation protocols / reportsKnowledge and understanding of USP, EP and ICH guidelinesIn-depth knowledge of GMPs and pharmaceutical regulationsAbility to communicate effectively with internal functions both in writing and verballyAbility to collaborate with contract testing laboratories, consultants, ensuring compliance with company proceduresPlease send resumes to tiffany@biophaseinc.com and visit our website at www.biophaseinc.com for additional job opportunities!!!