Senior Associate QA  (JP4488)

Location: Thousand Oaks, CA
Date Posted: 07-13-2018
Job Title: Senior Associate QA  (JP4488)
Location: Thousand Oaks, CA
Employment Type: Contract
Duration: 3 YEARS
Business Unit:  Cell Bank, DS, and DP Floor QA
3Key Consulting is looking for a Senior Associate QA  for a leading, international pharmaceutical company headquartered in Thousand Oaks, CA
 Job Details:
Candidate must be able to work day shift or swing shift. Candidate must be flexible to allow for shift changes. Candidate must be willing to work nights and weekends. 

Bulk Quality Assurance provides quality and compliance oversight of the manufacturing plant for the Drug Substance Intermediate, Drug Substance, and Drug Product stages. This includes cell bank, cell culture, purification, and aseptic formulation/fill/finish processes. The position also provides quality oversight of plant support functions such as maintenance, metrology, engineering, and automation. 


Provide Quality Assurance oversight for manufacturing and support operations for biopharmaceutical products. 
Ensure compliance to GMP regulations for area operations and associated or support processes. 
Support investigations/deviation reports (nonconformance reports). 
Management of GMP documentation including real time manufacturing document review, approval, and archiving. 
QA contact and approver for Class 1 Nonconformances. 
Provide plant floor Quality oversight to maintain an inspection ready facility as part of 75% required time on the manufacturing floor. 
May be asked to give additional assistance to management within the Quality Assurance group as needed. For example, metrics compilation or data gathering, project support, etc. 

Preferred Qualifications: 

Bachelor’s Degree in Biochemistry, Biology, Chemistry, or related science field. 
Demonstrated science based approach and an ability to deliver results. 
Experience working in multiple GMP databases. 
Demonstrated ability to perform GMP operations including following detailed SOPs, maintaining training, and good documentation practices. 
Experience in review and approval of batch records, NC/CAPA's and Change Control records. 
Demonstrated ability to use computer databases for query of data, managing status, and input of data and documentation. 
Previous experience in Amgen’s quality systems (SAP, LIMS, Change Control (CCMS), Trackwise, EDMQ, Maximo). 
Ability to focus on detail and ensure the accuracy of executed tasks and documentation per GMP standards. 
Effective verbal and technical written communication skills. 
Strong interpersonal skills to articulate quality requirements and rationale to others. 
Knowledgeable of regulatory requirements/Quality Principles. 
Able to effectively handle and operate in a rapidly changing environment. 
Strong team player. 
Complex decision making skills, ability to complete tasks autonomously, provide updates to area manager, and identify potential issues. 
Experience performing batch record review and previous manufacturing experience. 
Basic qualifications :

Master’s degree OR Bachelor’s degree and 2 years of quality experience OR Associate’s degree and 6 years of quality experience OR High school diploma / GED and 8 years of quality experience

  • Relevant experience in review and approval of batch records.
  • Relevant experience with quality systems such as NC, CAPAs, CCMS.
  • Manufacturing exp. a plus
  • Effective verbal and technical written communication skills
Provide quality oversite on the production floor. Batch record review. Review and approval of nonconformances. Review and approval of GMP documents. Collaboration with support groups and/or clients.
Previous contract worker got promoted to a full time position. This is a back fill role.
Potential to bring this person on as a full time employee after contract duration. Interact with high level stakeholders. Opportunity to work at a top bio-pharmaceutical company.
RED FLAGS: Do not meet experience requirements
INTERVIEW PROCESS:  phone screen In person - panel interview
We invite qualified candidates to send your resume to If you decide that you’re not interested in pursuing this position, please feel free to look at other positions on our website You are welcome to also share this posting with anyone you think might be interested in applying for this role.**No Third-party Vendors Please**
3KC Talent Acquisition Team
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