Quality Assurance Senior Associate JP10240
Quality Assurance Senior Associate JP10240
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Not Disclosed
Salary Not Disclosed
1 Vacancy
Job Description
Location: Thousand Oaks CA. 91320
Employment Type: Contract
Business Unit: Plant QA Drug Substances
Duration: 18 months (with likely extensions)
Notes: 100 Onsite. Must have Biotech/ Pharma experience required. Must be able to work swing morning evenings night shift 24/7 Operation building). Once trained it will 4 day work week. Must have proven Quality Assurance experience. Must have lab setting and quality background as they will be supporting the lab staff and provide quality oversight.
Posting Date: 05/10/22
3 Key Consulting is hiring a Quality Assurance Senior Associate for a consulting engagement with our direct client a leading global biopharmaceutical company.
Job Description:
The Senior Associate QA role supports clients Quality Assurance program providing daily oversight of Drug Substance manufacturing facilities at clients Thousand Oaks CA. facility. Under general supervision the role provides support and compliance oversight to MFG and F&E staff in the of their processes procedures and use of quality systems.
Duties include purposeful presence on the manufacturing floor batch record review SOP and MP revision approval work order approval and quality approval of deviations and CAPAs. Responsibilities will include evaluation of compliance issues providing recommendations and assuring progress of quality records to completion. The incumbent will also represent functional area quality for the Bulk Quality Assurance department in the of projects necessary to achieve departmental operational excellence goals and will work in a team matrix environment to ensure workplace safety.
This staff member will be assigned to provide quality support during either day or night shift schedule periods as operation support is 24/7.
Why is the Position Open
Supplement additional workload on team.
Top MustHave Skill Sets:
- Technical writing experience (i.e. deviation records CAPA records controlled documents)
- Excellent verbal and written cross functional communication skills
- Must have biotech/pharma manufacturing quality assurance or quality control experience
- Biotech/ Pharma experience required***
- Must be able to work swing morning evenings night shift 24/7 Operation building). Once trained it will 4 day work week.
Day to Day Responsibilities:
- Purposeful presence on the manufacturing floor 80 of working time spent on MFG floor in controlled classified cell culture and protein purification areas).
- Batch record review
- SOP and MP revision approval
- work order approval
- quality approval of deviations and CAPAs
- Safety auditing and observational work
- GEMBA walks
Red Flags:
- Not able to work onsite
- Unable to work shifts including morning evening or potentially nights
- No Biotech/ Pharma background/experience
- No quality assurance quality control experience
Interview process:
Phone screening followed by inperson interview.
We invite qualified candidates to sendyour resume to. Ifyou decide that youre not interested in pursuing this particular position please feel free to take a look at the other positions on our websitewww.3keyconsulting/careers. You are also welcome to sharethis opportunity withanyone you think might be interested in applying for this role.
Required Experience:
Senior IC
Employment Type
Full Time
