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Quality Control Senior Associate - Biotech (JP7227)

Thousand Oaks, California · Biotech/Pharmaceutical
Job Title:  Quality Control Senior Associate - Biotech (JP7227)
Location: Thousand Oaks, CA.
Employment Type:  Contract
Business Unit:  GRAAS Process Team
Duration: 12+ months with likely extensions
Posted Date: 04/22/2020 
Hourly rate: $18-22

3 Key Consulting is hiring a Quality Control Senior Associate for a consulting engagement with our client, a leading global biopharmaceutical company.
 
Ideal candidate:
  • Must have at least 2 year industry experience (non academia) in QC or R&D Lab based setting
  • Bachelors Degree in science or Engineering
  • Preferred: IS system experience (computer use), GMP experience
  • This is not a lab testing position. Candidate will be supporting IS system within QC (GMP/SOP/Maintaining systems)

Job Description:
Under general supervision, this position will perform routine administrative, documentation and execution processes relating to templating testing procedures into company’s electronic systems in support of the data acquisition integration. The systems will be Empower, LIMS, LMES, and CIMS.
 
This position will be responsible for one or more of the following activities:
  • Routing supporting documents,
  • Performing quality checks of templated information to confirm accuracy
  • Running scenarios to identify errors
  • Documenting outcomes of qualification activities, gathering feedback on requirements
  • Supporting administrative execution of qualification
  • Document management.
     
Must learn and comply with safety guidelines and cGMPs/CFRs which includes, but is not limited to, the maintenance of training records, laboratory documentation, written procedures.


Preferred Qualifications: Experience in Empower, LIMS, CIMS and/or LMES (SmartLab) or other electronic laboratory notebook. Ability to problem solve and troubleshoot lab testing technologies. Experience in QC testing, Experience in Manufacturing Practices

Top Must-Have Skill Sets:
?Experience with GMP document management systems (DMS) including document management
? years industry experience (non academia) in QC or R&D Lab based setting
?Proficient in Microsoft Office, Good Manufacturing Practices, Data Integrity Requirements of Quality Control Systems

Day to Day Responsibilities:
FIRST 30 DAYS: Will initially train on Documentum and Electronic Inventory IS system. Expected to train quickly and be able to review of templates for accuracy and document in Documentum before the end of 30 days. This position will perform routine processes relating to templating testing procedures into company’s electronic systems in support of the data acquisition integration initiative. This position will be responsible for one or more of the following activities:
- Performing quality checks of templated information to confirm accuracy
- Running scenarios to identify errors, documenting outcomes of qualification activities
- Gathering feedback on requirements
 
Employee Value Proposition:
Broad feeling and exposure to QC business & cross functional departments..
 
Red Flags:
Multiple short duration of any regular full time jobs and no working lab experience.
 
Interview process:
Phone & Skype interviews

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