Senior QC Associate

  • location: Novato, CA
  • type: Contract
  • salary: $44.51 - $52.36 per hour
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job description

Senior QC Associate

job summary:




As the world's largest staffing and recruitment agency in the world, we can commit to find you the perfect role that gives you the opportunity to learn and grow in the life sciences arena. Utilizing a recruiter for your job search gives you access to a large network of top employers as well as detailed information about hundreds of positions. Internationally known for creating cutting-edge biopharmaceuticals for patients who live with rare genetic diseases, our partner strives to develop critical therapies for the small population - mostly children - that suffer from near unheard of conditions. If you're looking for an exciting opportunity to make a difference with an established company, this is the position for you!



 
location: Novato, California
job type: Contract
salary: $44.51 - 52.36 per hour
work hours: 9 to 5
education: Bachelors
 
responsibilities:
This position will assist with the management of QC contract testing and cell bank production related activities.

  • Provide support in organizing QC contract testing and cell bank production activities.
  • Provide support in coordination of international shipments.
  • Liaise between contract laboratories and internal company groups.
  • Assist with management of in-country testing and provide updates to team and management.
  • Establish effective communication and collaborative relationships with other functional groups, key stakeholders, and external contacts.
  • Maintain tracking spreadsheets/databases for contract testing lab activities and information.
  • Organize and track contract testing and cell bank testing/production activities.
  • May generate and/or revise Quality Technical Agreements with contract testing labs and contract cell bank manufacturers.
  • Generate legal contract requests and purchase orders for contract testing and cell bank testing/production.
  • Initiate change requests (CR) for new cell bank production and SOP revisions using Track-Wise system.
  • Perform log-based cell bank inventories.
  • Request and coordinate cell bank vial shipments to/from offsite bio-repository.
  • Assist with shipment of samples and reagents to contract labs.
  • Manage and maintain good relationships with contract testing lab partners.
  • Support regulatory filings.
  • Support regulatory agency, partner and QP inspections.
 
qualifications:
  • B.S./B.A. degree with 6 years of experience in bio-pharmaceutical industry.
  • Thorough knowledge of cGMPs and regulations applicable to the FDA and comparable international regulatory agencies.
  • Excellent written and verbal communication skills
  • At least 6 years in the bio-pharmaceutical industry, with at least 2 years in a cGMP laboratory; quality control experience preferred.
  • Experience in dealing with contract testing laboratories is highly preferred.
  • Managerial/Supervisor experience is a plus.
  • Demonstrated ability to perform most tasks with minimal supervision given general instructions on routine work and instructions on new assignments.
  • Excellent organizational and project management skills.
  • Proficient in MS applications - Excel, PowerPoint, Word.
  • Knowledgeable and conversant concerning 21CFR, USP, EP, and ICH regulatory guidelines.
 
skills: Quality control, SOP, ICH Regulations, GMP (Good Manufacturing Practice)
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.

Qualified applicants in San Francisco with criminal histories will be considered for employment in accordance with the San Francisco Fair Chance Ordinance.

We will consider for employment all qualified Applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance.

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