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 execution 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 in-process 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 non-conformances 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 high-quality 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
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.
FMLA poster: https://www.dol.gov/whd/regs/compliance/posters/fmlaen.pdf
Know Your Rights: Know Your Rights: Workplace discrimination is illegal (eeoc.gov)
Employee Polygraph Protection Act: https://www.dol.gov/whd/regs/compliance/posters/eppac.pdf
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