QA Inspector, QA

Job Title: QA Inspector - 3rd Shift

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) OR up to 3 yeras of pharmaceutical experience

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

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