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Specialist Product Quality – REMOTE (JP9178)

Thousand Oaks, CA · Biotech/Pharmaceutical
Job Title:  Specialist Product Quality – REMOTE (JP9178)
Location: Thousand Oaks, CA. (100 REMOTE)
Employment Type:  Contract
Business Unit: PQ Synthetics and Quality Assurance
Duration: 3 years (with possible conversion to permanent)
Posting Date: 09/30/21


3 Key Consulting is hiring a Specialist Product Quality for a consulting engagement with our direct client, a leading global biopharmaceutical company.

Job Description:
B.S. in biochemistry, chemistry, biology, or a related protein or synthetic biotechnology sciences field or an equivalent level of biopharmaceutical experience with responsibility in a quality, analytical development, process development, or manufacturing environment- at least 10 years of experience. Familiar with pharmaceutical sciences, quality, compliance, and regulatory requirements, associated with biologics and synthetic chemical manufacturing and QC testing. Previous experience using VEEVA, Trackwise and other client quality systems. knowledge of biopharmaceutical bulk and drug product development, manufacturing, and/or Quality Control Testing

As a Product Quality (PQ) Quality Assurance (QA) Specialist, you will actively provide quality assurance support to the PQ organization as a subject matter expert of quality system records. In this team-based role you will directly add to the success of the Product Quality team by collaborating with diverse functional areas including Supply Chain, Manufacturing, Quality Control, Quality Assurance, Regulatory, Quality Engineering, International Quality and Process development on projects, issue resolution and investigations.

The QA Specialist will be encouraged to use technical abilities to lead and deliver quality assurance responsibilities while owning, reviewing, and/or approving Product Quality records and documentation including: product specifications, in-process control specifications, specification technical reports, annual product reviews (APRs), international expansion forms, change control records, appendix docs (data sheets and data analysis), Deviation Investigations/Root Cause Analysis, CAPAs, analytical comparability protocols, analytical comparability reports, and procedures.

As a team member you will be encouraged to use technical abilities to execute transactions in GMP systems (Veeva CDOCs, Trackwise, etc.) and may include additional business process support for APRs and site audits, as needed. The QA specialist may also help with guiding products through the annual product review cycles at client.

Why is the Position Open?
Supplement additional workload on team.

Top Must-Have Skill Sets:
  • Change control
  • Product specifications
  • Quality assurance in a GMP pharmaceutical environment
  • Pharmaceutical experience required
  • Quality assurance/ Quality systems experience highly preferred

Day to Day Responsibilities:
  • Successfully collaborate with functional groups to own and approve change records and deviations.
  • Quality review and approve product documents such as the APR, product specifications, comparability.

Basic Qualifications:
  • Doctorate Degree OR
  • Master's Degree & 3 years in Quality Assurance, Quality Control or Manufacturing OR
  • Bachelor's Degree & 5 years in Quality Assurance, Quality Control or Manufacturing OR
  • Associate's degree & 7 years in Quality Assurance, Quality Control or Manufacturing OR
  • High school diploma/GED & 10 years in Quality Assurance, Quality Control or Manufacturing

Preferred Qualifications:
  • Familiar with pharmaceutical sciences, quality, compliance and regulatory requirements, associated with biologics and synthetic chemical manufacturing and QC testing.
  • B.S. in biochemistry, chemistry, biology, or a related protein or synthetic biotechnology sciences field or an equivalent level of biopharmaceutical experience with responsibility in a quality, analytical development, process development, pharmaceutics, regulatory, or manufacturing environment.
  • Previous experience using VEEVA, Trackwise and other client quality systems.
  • Knowledge of biopharmaceutical bulk and drug product development, manufacturing, and/or Quality Control Testing
  • Strong project management skills.
  • General knowledge of cGMP and filing regulations, practices, and trends pertaining to the manufacture and testing of biopharmaceuticals.
  • Previous experience working on a cross-functional team in a matrix environment.
  • Excellent written and verbal communication skills, including facilitation and presentation skills.

Employee Value Proposition:
The person in this role will work with a unique quality assurance team. This team works at a high level and sees products across their life cycle.

Red Flags:
  • No bio/pharma experience
  • No entry level resumes

Interview process:
Video Skype Panel Interview


We invite qualified candidates to send your resume to resumes@3keyconsulting.com.  If you decide that you’re not interested in pursuing this particular position, please feel free to take a look at the other positions on our website www.3keyconsulting.com/careers. You are also welcome to share this opportunity with anyone you think might be interested in applying for this role.
 
 
Regards,
 
3KC Talent Acquisition Team
 
 
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