Quality Assurance Associate Biopharma Medical Device JP9524
Quality Assurance Associate Biopharma Medical Device JP9524
Posted on :
07-04-2025
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1 Vacancy
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Monthly Salary
Not Disclosed
Salary Not Disclosed
Vacancy
1 Vacancy
Posted on :
07-04-2025
Job Description
Job Title:Quality Assurance Associate Biopharma Medical Device (JP9524
Location:Thousand Oaks CA. Onsite
Employment Type: Contract
Business Unit:Plant Quality Assurance Incoming and Packaging
Duration:2 years with possible extension or conversion to FTE
Posting Date:12/14/2021
3 Key Consulting is hiring aQuality Assurance Associatefor a consulting engagement with our direct client a leading global biopharmaceutical company.
Job Description:
This position will provide operational QA support of a clinical drug product packaging and labeling team. Primary responsibilities will include review and approval of printed clinical labels finished clinical pack inspection expiration date calculation and batch record review. Secondary responsibilities will include generation and compilation of quality data and reports (e.g. lot track/trace deviations). Individual will also assist with procedure reviews and initiation of deviation reports. There is the potential for role expansion into support of a product distribution function.
Skills: quality assurance or manufacturing experience in the pharmaceutical or medical device industry
Must have experience with GMP processes and documentation. Without that fundamental skillset the training for document review tasks label approval and packaging inspection will have no foundation. Must be able to methodically and meticulously inspect printed materials for print quality defects clinical product components (e.g. syringes and vials) for physical defects and batch record documentation for accuracy and completeness. Must be able to work in a team with shifting priorities and shifting responsibilities such that the team members must be confident verbal communicators able to discuss responsibilities divide them reassess them and potentially reassign them throughout the day or week.
Top MustHave Skill Sets:
Day to Day Responsibilities:
Primary responsibilities will include review and approval of printed clinical labels finished clinical pack inspection expiration date calculation and batch record review. Secondary responsibilities will include generation and compilation of quality data and reports (e.g. lot track/trace deviations). Individual will also assist with procedure reviews and initiation of deviation reports. There is also the potential for role expansion into support of a product distribution function.
Employee Value Proposition:
Good team atmosphere and supportive team
Opportunity to learn and grow
Red Flags:
* Jumping from position to position
* Lack of attention of details
* A minimum of 1 year of experience in Quality Assurance
Interview process:
Phone screen
Virtual 1:1 45 minutes 60 with panel
We invite qualified candidates to sendyour resume to. Ifyou decide that youre not interested in pursuing this position please feel free to take a look at the other positions on our websitewww.3keyconsulting/careers. You are welcome to also sharethis opportunity withanyone you think might be interested in applying for this role.
Location:Thousand Oaks CA. Onsite
Employment Type: Contract
Business Unit:Plant Quality Assurance Incoming and Packaging
Duration:2 years with possible extension or conversion to FTE
Posting Date:12/14/2021
3 Key Consulting is hiring aQuality Assurance Associatefor a consulting engagement with our direct client a leading global biopharmaceutical company.
Job Description:
This position will provide operational QA support of a clinical drug product packaging and labeling team. Primary responsibilities will include review and approval of printed clinical labels finished clinical pack inspection expiration date calculation and batch record review. Secondary responsibilities will include generation and compilation of quality data and reports (e.g. lot track/trace deviations). Individual will also assist with procedure reviews and initiation of deviation reports. There is the potential for role expansion into support of a product distribution function.
Skills: quality assurance or manufacturing experience in the pharmaceutical or medical device industry
Must have experience with GMP processes and documentation. Without that fundamental skillset the training for document review tasks label approval and packaging inspection will have no foundation. Must be able to methodically and meticulously inspect printed materials for print quality defects clinical product components (e.g. syringes and vials) for physical defects and batch record documentation for accuracy and completeness. Must be able to work in a team with shifting priorities and shifting responsibilities such that the team members must be confident verbal communicators able to discuss responsibilities divide them reassess them and potentially reassign them throughout the day or week.
Top MustHave Skill Sets:
- 1 GMP processes and documentation experience
- Good Manufacturing practices
- Inspection and QA background.
- Attention to detail; assign expiration dates on labels providing info on labels and documentation
- Packaging experience is preferred
Day to Day Responsibilities:
Primary responsibilities will include review and approval of printed clinical labels finished clinical pack inspection expiration date calculation and batch record review. Secondary responsibilities will include generation and compilation of quality data and reports (e.g. lot track/trace deviations). Individual will also assist with procedure reviews and initiation of deviation reports. There is also the potential for role expansion into support of a product distribution function.
Employee Value Proposition:
Good team atmosphere and supportive team
Opportunity to learn and grow
Red Flags:
* Jumping from position to position
* Lack of attention of details
* A minimum of 1 year of experience in Quality Assurance
Interview process:
Phone screen
Virtual 1:1 45 minutes 60 with panel
We invite qualified candidates to sendyour resume to. Ifyou decide that youre not interested in pursuing this position please feel free to take a look at the other positions on our websitewww.3keyconsulting/careers. You are welcome to also sharethis opportunity withanyone you think might be interested in applying for this role.
Regards
3KC Talent Acquisition Team
Required Experience:
IC
Employment Type
Full Time
Key Skills
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