QA Inspector 3pm-1130pm

Nature and Scope
This position is responsible for providing Quality oversight in manufacturing areas including but not limited to Formulation Filling Inspection Equipment Prep and Packaging through the of site policies and procedures programs and work instructions. This position ensures all processes and products meet specifications and that products are produced in accordance with cGMP requirements. The QA Inspector maintains compliance with quality programs.

Essential Duties and Responsibilities

• All inspections are conducted in compliance with the Code of Federal Regulations (CFR 211.134 Drug product inspection.

• Achieve and maintain Aseptic Processing Area (APA) gown qualification.

• Adhere to all SOP related to working in an aseptic environment including volume/weight checks of product filled in vials and ampoules; s well as the monitoring of personnel Aseptic Technique.

• Checks product lot number information documents in the batch record where applicable and reviews Master Batch Records for accuracy at all stages in the manufacturing process Formulation Filling Inspection and Packaging.

• Conducts product inprocess inspections at designated intervals.

• Determines the Acceptable Quality Limits (AQL) by using the (American Nation Standards Institute) ANSI Z1.4 Standard Inspectors Rule the ruler assists with the calculation of sample size and Accept/Reject (A/R) numbers.

• Conducts inspection of formulation equipment (e.g. tanks) for cleanliness imperfections and acceptable operating condition.

• Documents verification of task performed (where applicable).

• Conducts visual inspection of filled vials and ampoules after manual or automated inspection for defined critical major and minor defects as well as particulate matter.

• Conducts inspection of printed materials (e.g. labels) inserts finished units unit packs and shipping containers for critical major and minor defects.

• Perform monthly inspection of the retentions samples to ensure quality of finished products until expiration.

• Assist in the management of the sample retention room (removing samples for monthly inspections putting away samples from monthly inspections adding new samples to the room and removing samples from the room that have expired).

• Reports all nonconformances to supervision.

Education Requirements and Qualifications

• High School Diploma or GED equivalent required.

• 1 year of related experience in Quality Assurance and/or manufacturing within a cGMP environment preferred.

• Experience in a pharmaceutical biotech food or related manufacturing environment preferred.

• Working knowledge of good manufacturing systems familiarity with regulatory and manufacturing SOPs and cGMPs preferred.

• Ability to perform accurate mathematical calculations required.

• Basic computer skills including Microsoft Outlook Word Excel required.

• Strong attention to detail adherence to SOPs and a desire for ensuring a highquality product.

• Must be able to read documents in Standard English such as Standard Operating Procedures maintenance schedules and operating manuals.

• Ability to meet and maintain sterile gowning requirements.

• Ability to work overtime as needed including weekends when required.

Physical Environment and Requirements

• Employee must be able to occasionally lift and/or move up to 25 pounds.

• Physically able to wear cleanroom/protective gowning and equipment including but not limited to gowning goggles face shields respirators and protective gloves. PPE and Respirators are essential for the health and safety of employees.

• Specific vision requirements include 20/20 near vision (can be corrected with eyeglasses or contacts) and color vision.

Expected Hourly Rate:

$23.61$25.00

The hourly rate displayed is the minimum and maximum hourly rate of compensation for the role that the employer in good faith believes to be accurate at the time of the posting of an advertisement for the role. Actual compensation for the role will be based on a number of different factors including but not limited to the candidates qualifications education knowledge skills and experience.

American Regent also offers a competitive total rewards package which includes healthcare life insurance profit sharing paid time off matching 401k as well as a wide range of other benefits.

American Regent celebrates diversity and we are committed to creating an inclusive environment for all employees. We are an Equal Opportunity Employer and all qualified applicants will receive consideration for employment without regard to race color religion sex sexual orientation gender identity national origin disability status or protected veteran status.

Applicants have rights under Federal Employment Laws.

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