Compliance Specialist, Analytical Development

Position Title: Compliance Specialist, Analytical Development
Work Location: Gateway Boulevard, Newark, CA
Assignment Duration: 12 months
Work Arrangement: Onsite

Position Summary: The client is seeking a Compliance Specialist to contribute to our growing Analytical Development team. The Compliance Specialist will participate in all aspects of compliance and development management in Analytical Development, working closely with cross-functional teams to onboard instruments/equipment, performing data/document/record review, and authoring various compliance documents.

Key Responsibilities:

• Work closely with the CMC team to manage and coordinate analytical activities
• Manage early and/or late phase drug substance and drug product analytical activities at contract testing laboratories (method development, method qualifications/validations, method transfers, analytical investigations support)
• Execute technical analytical methodologies to support development and validation of test methods.
• Author and review raw data (e.g. stability data packages and ad hoc testing), analytical methods, protocols, reports, and other technical documents, including instrument qualification and change control.
• Assist in authoring and reviewing various regulatory submission and interaction documents
• Assist in the developing, authoring, and/or reviewing standard operating procedures
• Manage reference materials and reference standards inventory and (re)qualification testing
• Manage vendor maintenance and calibration for AD-owned equipment, instruments, and systems
• Ensure adherence to GMPs, GLPs, GCPs and GDPs where required.

Qualification & Experience:

• Bachelor’s degree in biological sciences or related field with 4+ years of progressive experience in the biotechnology or pharmaceutical industry.
• 3+ years of experience in a regulated/GMP environment.
• 2+ years of experience in a quality function (QC or QA organization)
• Experience in drafting protocols, methods, reports, and/or procedures.
• Experience in performing change control, deviation, laboratory investigation, and/or other quality records.
• Be able to communicate technically and strategically across technical and operational activities and work collaboratively to ensure successful execution.
• Strong written and verbal communication skills.
• Working knowledge of statistics; R, Python, or other statistical tools preferred.
• Ability to work on multiple projects simultaneously, demonstrating organizational and problem-solving skills.
• Self-motivated, proactive and driven individual with an interest in experimental design and development.
• Demonstrated experience in managing outsourced analytical activities
• Demonstrated experience in QC data review of release and stability data packages
• Experience in Liquid Chromatography and/or Immunoassays is highly desired.

 
 
At SPECTRAFORCE, we are committed to maintaining a workplace that ensures fair compensation and wage transparency in adherence with all applicable state and local laws. This position’s starting pay is: $ 50.70/daily.