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QA Specialist

Company: Pharmacyclics, LLC
Location: Sunnyvale
Posted on: May 18, 2019

Job Description:

Pharmacyclics is committed to the development and commercialization of novel therapies intended to improve the quality and duration of life and to resolve serious unmet medical needs for cancer patients. Pharmacyclics is a wholly-owned subsidiary of AbbVie (NYSE:ABBV), a global, research-based biopharmaceutical company. Oncology is a key therapeutic area for AbbVie, with a portfolio consisting of three marketed products and a pipeline containing multiple promising new molecules that are being studied in more than 200 clinical trials for over 20 different types of cancer. More than 1,200 Pharmacyclics and AbbVie research scientists, clinicians, marketing, operations and corporate professionals work in the San Francisco Bay Area. They combine their expertise in immuno-oncology, stem cells, and cell-signaling with their knowledge of bispecific antibodies, antibody-drug conjugates (ADCs), and covalent-inhibitor technologies to discover and develop novel cancer treatments. Together, we are striving to outsmart cancer. General Position Summary:

  • Provide support in maintaining 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: Vendor Management, Audit Program, Quality Metrics, Management Review, Change Control, Investigations/CAPAs, and Validations while ensuring compliance with PCYC procedures, AbbVie Policies, and cGMPs. Key Accountabilities/Core Job Responsibilities:
    • Responsible for QA related tasks in support of Quality Systems, including QA review and approval of documents and execution of transactions (Owner and/or QA Contact) in relevant GMP systems (Change Control, Deviation/CAPA, etc.).
    • Support continuous improvement initiatives intended to increase Quality systems efficiencies within and external of the Quality organization. Operate as a liaison with the various technical, regulatory and Quality functions to ensure strategic alignment and compliance with PCYC and AbbVie Quality System requirements
    • Support other Quality System functions as assigned by Quality Management that are related to documentation creation/revision, Nonconformance review, Corrective and Preventative Actions, Risk Management, Training, product investigations, audits, and other tasks as directed
    • Facilitate change management process by facilitating and collaborating with functional (Department) representatives the review and approval of proposed change and management of implementation activities to closure.
    • Participate in management reviews. Prepare and present applicable quality metrics.
    • Support and participate in regulatory inspections and internal audits.
    • Support and participate in Quality investigations, as required.
    • Supports the internal CMC team, as required. Education and Training: (degrees, certifications)
      • Bachelor's Degree or equivalent professional experience B.A. or B.S. degree preferably in scientific or technical field (e.g., chemistry, biology, physics, engineering, computer science, technical writing) or experience and training equivalent to such a degree. Experience:
        • Four (4) or more year experience working in a cGMP regulated environment such as the field of quality assurance, quality control, and/or manufacturing operations, applying the cGMP rules in everyday activities.
        • Knowledge of pharmaceutical manufacturing process and FMEA Quality Risk Assessment knowledge.
        • Hands on experience with quality systems in a GMP environment and experience with FDA and other health authority inspections Specific Skills/Abilities:
          • Excellent working knowledge of global GMP regulations, ICH guidelines and robust Quality Systems.
          • Broad experience in the pharmaceutical industry with a strong analytical background.
          • Detail oriented with demonstrated problem-solving acumen.
          • Possess/demonstrated organizational skills that have proven results in the ability to be self-directed while managing multiple projects.
          • Ability to work effectively in a team environment with great organization skills.
          • Ability to independently analyze and reconcile complex issues.
          • Must be an individual with proven initiative and accountability
          • Must be able to work in a fast-paced environment.
          • Excellent verbal and written communication and interpersonal skills.
          • Proficient with Quality Management Systems such as Trackwise.
          • Possess an industry best practices perspective. ---#LI-SH24 Equal Opportunity Employer Minorities/Women/Veterans/Disabled

Keywords: Pharmacyclics, LLC, Sunnyvale , QA Specialist, Other , Sunnyvale, California

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