Randstad Quality Control Specialist in Novato, California

Quality Control Specialist

job details:

  • location:Novato, CA

  • salary:$31.50 - $37.16 per hour

  • date posted:Wednesday, February 6, 2019

  • experience:5 Years

  • job type:Contract

  • industry:Professional, Scientific, and Technical Services

  • reference:27713

job description

Quality Control Specialist

job summary:

Senior QC Associate

Job Summary

This position will assist with the management of QC contract testing and cell bank production related activities.

location: Novato, California

job type: Contract

salary: $31.50 - 37.16 per hour

work hours: 9 to 5

education: Bachelors


Job Responsibilities

  • 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 managment.

  • 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 TrackWise system.

  • Perform log-based cell bank inventories.

  • Request and coordinate cell bank vial shipments to/from offsite biorepository.

  • 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.


Education & Qualifications

  • B.S./B.A. degree with 4 years of experience in pharmaceutical industry, including some work in a laboratory setting.

  • Thorough knowledge of cGMPs and regulations applicable to the FDA and comparable international regulatory agencies.

  • Excellent written and verbal communication skills

  • At least 4 years in a cGMP laboratory; quality control experience required.

  • Experience in dealing with contract testing laboratories is highly preferred.

  • Well-developed laboratory skills for analysis of pharmaceuticals and biopharmaceuticals.

  • Demonstrated ability to perform most tasks with minimal supervision given general instructions on routine work and detailed instructions on new assignments.

  • Proficiency in MS Applications

  • Excellent organizational and project management skills.

  • 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.