Associate QA – Biopharma Packaging & Labeling (JP5006)
Thousand Oaks, Ca.
18 months with likely extension
Quality Assurance - Packaging QA
3Key Consulting Inc. is looking for an entry level Quality Assurance Associate
with 1-3 years’ experience GMP systems, for a global bio-pharmaceutical company.
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
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
Top Must Have Skill Sets:
Employee Value Proposition:
- 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.
For an individual with a desire to get a start into Amgen, this role is a great opportunity. These positions very frequently result in full time hire at Amgen for the individual who comes in with a determination to succeed and establish a positive reputation for him/herself. This position is part of a larger organization providing support to over a half dozen operations buildings on the Amgen Thousand Oaks campus, so the excellent performer may see opportunities open up in Manufacturing, Quality Assurance and the Quality Control Laboratories. This is a good role for someone coming out of school with a basic understanding of the biotechnology processes and GMP documentation. It will provide the individual an opportunity to expand their knowledge and experience in a setting that is not overly challenging from a scientific perspective but will show them a view of clinical manufacturing that looks at both the Amgen supply processes and the clinical demand drivers.
Total lack of background in GMP operations. If that background is in their education only, for the right candidate, that might be acceptable, but most likely the successful candidate will have at least some experience with the rigor of documentation required for operations in a GMP environment. The role will be reviewing labeling and packaging batch records, so the individual will need to have a careful, thorough style that is most typically associated with a foundation in GMP operations. Otherwise, all red flags are behavioral. Ideally, the candidate will be a dynamic person who enjoys frequent team interaction and who shows a sense of ownership over any issues that arise so that no issue or risk goes unresolved, at least enough ownership to identify the appropriate experts to resolve the issue and communicate clearly to them.
Phone screen followed by onsite interview.
We invite qualified candidates to send your resume to firstname.lastname@example.org
. 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. You are welcome to also share this posting with anyone you think might be interested in applying for this role.