AbbVie Pharmacyclics Senior Quality Assurance Specialist in Sunnyvale, California

Senior Quality Assurance Specialist

Location: Sunnyvale, CA

# of Openings: 1

Description

General Position Summary:

Executes and maintains compliant, efficient internal quality systems and procedures related to the manufacture, packaging, testing, and disposition of drug substances and drug products at CMOs. Quality systems include, but are not limited to: Annual Product Review, Product Complaints, Vendor Management, Quality Metrics, Management Review, Change Control, Investigations/CAPAs, and Validations.

Key Accountabilities/Core Job Responsibilities:

  • Independently reviews and approves master batch records, labels, specifications, and other manufacturing documents of clinical and commercial drug substances and drug products in compliance with all applicable requirements.

  • Independently reviews and approves executed manufacturing records, analytical data, and associated documentation, including deviations and investigation reports related to production and disposition.

  • Performs Quality investigations.

  • Reviews and approves change control requests to ensure compliance with all applicable requirements.

  • Representative on internal CMC team.

  • Participates in or leads internal audit and vendor management programs.

  • Prepares quality metrics.

  • Initiates SOP updates and creation of new SOPs.

  • Quality representative for regulatory inspections.

  • Assists in establishment of Quality-specific documents (e.g., Quality Risk Management Plan, Quality Agreements, Site Master File, and Validation Master Plan).

  • Ensures Quality processes at PCYC and across the supply chain comply with all applicable regulations and guidelines.

Education and Training: (degree, certifications, etc.)

  • Minimum BA/BS degree preferably in a scientific discipline.

Experience:

  • 2-6 years of pharmaceutical experience in a GMP environment.

Specific Skills/Abilities

  • Excellent working knowledge of Quality Systems, GMP-related requirements and ICH guidelines.

  • Experience in the pharmaceutical industry with a strong analytical and/or manufacturing background.

  • Detail oriented with solid problem solving acumen.

  • Ability to work effectively in a team environment with great organization skills.

  • Ability to independently analyze and reconcile moderate to complex issues.

  • Must have demonstrated initiative and accountability in a fast paced environment.

  • Must demonstrate leadership skills through example.

  • Excellent verbal and written communication and interpersonal skills.

Proficient with computers and word processing software (i.e., Microsoft Office products

Equal Opportunity Employer Minorities/Women/Veterans/Disabled