QA Specialist II

South San Francisco, CA 94080

Posted: 01/26/2018 Employment Type: Contract Industry: Clinical & Scientific Job Number: 12476

Bayside Solutions is seeking a QA Specialist II to be part of our Client’ s team in South San Francisco. This is an opportunity to work with a local Biotechnical company focusing on the discovery, development, manufacturing and commercialization of medicines to treat patients with serious or life-threatening medical conditions.

Our Company Bio:  Bayside Solutions was founded in 2001, Bayside was recognized as one of the fastest growing professional staffing companies in Northern California. The numbers tell the story: We have close to a 100% client retention rate, 700% growth in four plus years and over 95% repeat business. Our dedication to building partnership relationships with both our clients and our recruits is the key to our phenomenal success.

You can find additional information on our company website

QA Specialist II

Job Benefits:
  • An opportunity to join a patient-focused organization that is driven to develop and commercialize novel drugs for treating rare diseases.
  • Work for a company that is local to the bay area and recognized as a leader of innovation.  
  • Competitive compensation commensurate with experience.
  • This position is eligible for medical, vision, dental benefits, paid sick time, and 401K.

Summary of Responsibilities:
  • Provide on-the-floor day to day Quality support to clinical packaging and warehousing operations.
  • Perform routine Manufacturing Quality Assurance tasks, including labeling printing approval, line clearance, QC sampling, and AQL inspection to support clinical packaging and lot release.
  • Perform final review of manufacturing batch records for Genentech manufactured cell banks and clinical large molecule drug substance, drug product and final drug product.
  • Compile Batch History Records for Product Manager review.
  • Scan documents into our GMP document management system.
  • Review and Interact with interdepartmental contacts on discrepancy assessment, resolution, and quality approval.
  • Provide Quality oversight to internal customers in the Manufacturing organization.
  • Collaborate with departments to ensure that all review activities are executed efficiently and effectively.
  • Make independent decisions around complex issues in alignment with GNE policies.
  • Identify and implement process improvements, as necessary.

Required Qualifications:
  • BS/BA degree in the life sciences plus 5-7 years experience.
  • A minimum of at least 5 years experience in Quality Assurance, Quality Control, Manufacturing, or equivalent experience. 
  • Thorough knowledge of cGMPs (Drugs and Biologics), and regulations applicable to U.S. and international Regulatory agencies.
  • Knowledge of cGMPs or equivalent regulations strongly preferred.
  • Ability to interpret Quality standards for implementation.
  • Ability to independently evaluate situations and propose potential solutions.
  • Ability to interpret Quality standards for implementation.
  • Aility to communicate clearly and professionally both in writing and verbally.
  • Flexibility in problem solving and work hours to meet business objectives.
  • Knowledge of SAP and Trackwise applications and project management skills are highly desirable.
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