What are the responsibilities and job description for the Compliance Specialist – Analytical Development position at TalentBurst, an Inc 5000 company?
Job Title: Compliance Specialist - Analytical Development
Location: Newark, CA (Onsite)
Duration: 12-Month Contract
Job Summary
Client is seeking a Compliance Specialist to support the Analytical Development team in Newark, CA. This role will contribute to compliance and development activities within Analytical Development, working closely with cross-functional teams to onboard instruments and equipment, perform data, document, and record reviews, and author various compliance and regulatory documents.
This position may also require hands-on laboratory work to support analytical testing of drug substances and drug products, enabling phase-appropriate analytical development for clinical programs through commercial registration and post-approval improvements.
This is an onsite, laboratory-based role focused on analytical method development, validation, and compliance for biologics, collaborating with teams across Process Development, R&D, Formulation Development, Quality Control, and other technical groups.
Key Responsibilities
Collaborate with the CMC team to manage and coordinate analytical development activities.
Manage analytical activities for drug substance and drug product testing at contract testing laboratories, including:
Method development
Method qualification and validation
Method transfers
Analytical investigation support
Perform analytical testing and execute technical methodologies to support development and validation of test methods.
Author and review raw data, analytical methods, protocols, reports, and technical documentation, including stability data packages and ad-hoc testing reports.
Support instrument qualification, change control documentation, and analytical development compliance activities.
Assist with the preparation and review of regulatory submission documentation and regulatory interaction materials.
Develop, author, and review Standard Operating Procedures (SOPs).
Manage reference standards and reference materials inventory, including qualification and requalification testing.
Coordinate vendor maintenance, calibration, and servicing of Analytical Development equipment and instrumentation.
Ensure adherence to GMP, GLP, GCP, and GDP regulations and company quality standards.
Required Skills & Qualifications
Experience drafting analytical protocols, methods, reports, and SOPs.
Experience managing change control, deviations, laboratory investigations, and quality documentation.
Ability to communicate effectively across technical and operational teams.
Strong written and verbal communication skills.
Working knowledge of statistical analysis; experience with R, Python, or other statistical tools is a plus.
Ability to manage multiple projects simultaneously with strong organizational and problem-solving skills.
Self-motivated and proactive individual with interest in experimental design and analytical development.
Preferred Qualifications
Experience managing outsourced analytical activities with CROs or contract testing laboratories.
Experience reviewing QC release and stability data packages.
Experience with Liquid Chromatography (HPLC/LC) and/or Immunoassays.
Prior experience supporting biologics analytical development.
Education & Experience
Bachelor's degree in Biological Sciences, Chemistry, Biochemistry, or related field.
4 years of 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).
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