The QA Inspector monitors in-process product quality for Filling and Inspection and Packaging of parenteral products. The QA Inspector performs visual and functional testing of products against statistically based sampling plans. In addition, the QA Inspector performs routine inspection and testing of components following Standard Procedures and specifications as required by production schedules. In performing the above duties, the individual is responsible for accurately and clearly documenting test results following cGMPs. This position participates in rotation for weekend coverage and as needed during the work week.
- Performs in-process monitoring (Filling room, Inspection/packaging lines, Oxygen headspace testing, and Osmolality testing).
- Contact QA Coordinator or QA Supervisor for daily line assignments and in response to OOS results and manufacturing deviations.
- May perform routine inspection and testing of components.
- Samples/Checks/Verifies Controlled Substances during in-process monitoring.
- Prepares and /or issues Batch record documents when needed.
- Test-filled units using analytical instrumentation such as Analytical balances and Gas Chromatographs.
- Maintains good housekeeping and safe working conditions.
- Accurately and clearly documents inspection/test results in accordance with department and site SOPs.
- Performs other duties to support production or validation as determined by the QA Supervisor.
- Participates in rotation for weekend coverage to support production. May work flexible hours and overtime on short notice to support production.
- Uses laboratory instrumentation, syringes, reagents, and compressed gases daily.
QUALIFICATIONS - Minimum: Associates Degree in Science or equivalent with 1-2 years applicable laboratory, pharmaceutical manufacturing, or related experience (QA preferred)
- Preferred: Bachelor's Degree in Science or equivalent with 0-2 years applicable laboratory, pharmaceutical manufacturing, or related experience (QA preferred)
EXPERIENCE - Minimum: 0-2-year applicable laboratory or pharmaceutical production experience (QA preferred).
SKILLS - Possesses proficient mathematical skills (addition, subtraction, multiplication, division, algebra, unit conversions, rounding significant figures, dividing polynomials, solving rational equations).
- Familiar with cGMPs, EU, CFR, and the USP
- Demonstrates good attention to detail and accuracy
- Good organizational skills and ability to multi-task and perform work promptly
- Demonstrates ability to work in a team environment with good communication skills and ability to communicate effectively with peers, department management, and production personnel
- Knowledge of computer systems at a level proficient in navigating input and/or reference computerized data
- Must have sound judgment and demonstrate good analytical skills to assess risk to issues related to the manufacturing process
- Must be able to pass the vision requirements established for the Inspector position
- Ability to walk from line to line 85% of the shift
- Good manual dexterity to repetitively manipulate syringes to sample filled units for in-process monitoring
- Good close visual acuity (eye exam required)
- Noise levels on production lines may be moderate to high
- Able to lift 15lbs.
What We Offer - Clean climate-controlled working environment
- Annual performance bonus potential
- 401k employer match up to 6% of your contributions
- 23 vacation/personal days
- 11 paid Company holidays
- Generous healthcare benefits
- Employee discount program
- Wellbeing rewards programs
- Safety and Quality is a top organizational priority
- Career advancement/growth opportunities
- Tuition Reimbursement
- Maternity and Parental Leave
*Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to a specific plan or program terms Location: