Quality Operations Associate
Los Angeles Metro Area, CA
The Quality Operations Associate I is responsible for performing quality functions in the packaging and 100% final container inspection process.
1. Responsible for quality oversight of the final container inspection and packaging operations. For example, AQL (Acceptable Quality Limit) sampling and inspection of packaged final container product, packaging area release, quality verification of first print and last print samples, lot
2. Perform Label Control duties, i.e. inventory count and issuance of labels and inserts for the packaging process.
3. Receive, store and inspect retention samples (includes intermediates and final container products).
4. Inspect and release finished product produced.
5. Perform annual inventory of quarantine areas and quarterly inventory of label control areas.
6. Perform distribution release verification of intermediates and final container products.
7. Perform packaging work order review.
8. Perform various SAP transactions from the processes mentioned above.
9. Strict adherence to procedures and practices according to FDA regulations.
10. Strong emphasis on documentation according to FDA regulations.
11. Adhere to departmental corporate safety policies.
Related experience in a pharmaceutical, GMP, or FDA regulated environment is preferred.
Requires a basic understanding of quality inspection and label control.
Strong organizational, analytical, and problem-solving skills with the ability to make structured decisions on a routine basis.
Must be proactive, results oriented, and have strong attention to detail.
Self-starter with strong work ethic and the ability to exercise good judgment.
Ability to effectively prioritize and manage multiple tasks to meet targeted deadlines.
Strong interpersonal skills with the ability to interact with personnel at all levels in a team environment.
Excellent verbal and written communication skills in the English language.
Computer literacy with proficiency in MS Office (Outlook, Word, Excel, PowerPoint).
Specific experience with SAP is preferred.
Must be flexible with working hours / shifts in order to accommodate the 24 hour, 7 day plant operation.
1. Ability to lift /move up to 50 pounds.
2. Ability to stand for extended periods - up to four (4) hours at a time.
3. Manual dexterity to perform all job functions.
4. Exposure to toxic/caustic chemicals and biological hazards.
5. Must have 20/20 vision, or correctable to 20/20 vision.
6. Must have color perception/discrimination for inspection and/or testing.
Associate degree in Biology, Chemistry, Chemical Engineering or closely related scientific
discipline is required.
Bachelor's degree preferred.
Hep B Notification required.
Vision test/Color vision test