Qa Inspector, 2Nd Shift

The QA Inspector monitors in-process product quality for Filling and Inspection and Packaging of parenteral products. The QA Inspector is responsible for performing visual and functional testing of product against statistically based sampling plans. In addition, the QA Inspector performs routine inspection and testing of components in accordance with Standard Procedures and specifications as required by production scheduling. In performing the above duties, the individual is responsible for accurately and clearly documenting test results in accordance with cGMPs. This position participates in rotation for weekend coverage and as needed during the work week.

• Performs other duties to support production or validation as determined by QA Supervisor.
• Maintains good housekeeping and safe working conditions.
• May perform routine inspection and testing of components.
• Test filled units using analytical instrumentation such as Analytical balances and Gas Chromatograph.
• Samples/Checks/Verifies Controlled Substances during in-process monitoring.
• Accurately and clearly documents inspection/test results in accordance to department and site SOPs.
• Participates in rotation for weekend coverage to support production. May work flexible hours and overtime on a short notice to support production.
• Prepares and /or issues Batch record documents when needed.
• Contacts QA Coordinator or QA Supervisor for daily line assignments and in response to OOS results and manufacturing deviations.
• Uses laboratory instrumentation, syringes, reagents and compressed gases on a daily basis.
• Performs in-process monitoring (Filling room, Inspection/packaging lines, Oxygen headspace testing and Osmolality testing).

QUALIFICATIONS

• Preferred: Bachelor’s Degree in Science or equivalent with 0-2 year applicable laboratory, pharmaceutical manufacturing or related experience (QA preferred)
• Minimum: Associates Degree in Science or equivalent with 1-2 year applicable laboratory, pharmaceutical manufacturing or related experience (QA preferred)

EXPERIENCE

• Minimum: 0-2-year applicable laboratory or pharmaceutical production experience (QA preferred).

SKILLS

• Knowledge of computer systems at a level proficient to navigate input and/or reference computerized data
• Possesses proficient mathematical skills (addition, subtraction, multiplication, division, algebra, unit conversions, rounding significant figures, dividing polynomials, solving rational equations).
• Demonstrates good attention to detail and accuracy
• Must be able to pass the vision requirements established for the Inspector position
• Familiar with cGMPs, EU, CFR and the USP
• Good organizational skills and ability to multi-task and perform work in a timely manner
• Must have sound judgment and demonstrate good analytical skills to assess risk to issues related to the manufacturing process
• Demonstrates ability to work in a team environment with good communication skills and ability to communicate effectively with peers, department management and production personnel

• 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
• Noise levels on production lines may be moderate to high
• Able to lift 15lbs.
• Good close visual acuity (eye exam required)

What We Offer

• Annual performance bonus potential
• Employee discount program
• 11 paid Company holidays
• Safety and Quality is a top organizational priority
• Career advancement/growth opportunities
• Tuition Reimbursement
• 401k employer match up to 6% of your contributions
• Maternity and Parental Leave
• Clean climate-controlled working environment
• Generous healthcare benefits
• Wellbeing rewards programs
• 23 vacation/personal days

• 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.