QA Operations Associate II

American Regent, Inc.; New Albany (IN); On-site; USD 60,000 - 90,000; Full time

Job summary

American Regent Inc. in New Albany, IN, seeks a quality-focused professional to ensure product quality in GMP manufacturing. This role executes site policies, conducts inspections, and supports root-cause investigations for deviations.

You will collaborate across departments, maintain SOPs, perform document control, and assist in compliant release of components while upholding safety standards. Strong attention to detail required.

Qualifications

• High School Diploma or GED equivalent required; Associates or Bachelor's Degree preferred.
• At least two years of related experience in QA, Compliance, Auditing, Laboratory or Inspection in a GMP environment.
• Experience in QA within a cGMP manufacturing environment is preferred.
• Strong analytical skills, attention to detail and adherence to procedures.
• Proficient with MS Word and Excel; ability to work overtime as needed.

Responsibilities

• Achieve and maintain equipment and room clearance qualification.
• Conduct verifications, checks and in-process inspections with accuracy.
• Identify out-of-spec products and ensure proper escalation and segregation.
• Resolve errors per SOPs and guide plant personnel on document corrections.
• Ensure work aligns with company policies, cGMP, and safety requirements.
• Release components and raw materials; monitor charts and escalate as required.
• Support shipping activities and oversee quality-related verifications.
• Generate controlled documents and review Bills of Materials.
• Maintain gowning qualifications and participate in Media Fill programs.
• Collaborate with other departments to implement procedural changes and resolve compliance issues.

Skills

QA

Compliance

Auditing

GMP

SOP

Documentation

Problem solving

Root cause analysis

Education

Associates or Bachelor's Degree preferred

Tools

MS Word

Excel

Job description

Nature and scope

This position is responsible for ensuring the overall quality in their assigned areas through the execution of site policies and procedures, programs and work instructions. Ensures all processes and products meet specifications and that products are produced in accordance with GMP requirements. This position requires working closely with other departments on production issues/situations, product dispositions and investigations into root causes for deficiencies.

Essential duties and Responsibilities

Nothing in this job description restricts management’s right to assign or reassign duties and responsibilities to this job at any time.

• Achieve and maintain equipment and room clearance qualification.
• Conduct accurate verifications and checks and during in-process inspections
• Identify out of specification product, ensuring segregation and escalation, as required
• Ensure errors and omissions are resolved according to Standard Operating Procedure (SOP) requirements, providing guidance to plant personnel on document corrections and investigations
• Ensure all work is performed and documented in accordance with existing Company policies and procedures, as well as cGMP, health and safety requirements.
• Conduct component and raw material release
• Conduct chart monitoring, ensuring escalation, as required
• Support product shipping activities and perform quality related oversight and verifications
• Generate controlled documents such as logbooks and labels.
• Review Bills of Materials
• Achieve and maintain clean side gown and sterile side gown qualifications
• Participate in Media Fill and maintain qualification.
• Partner with other departments to implement timely procedural changes and resolve compliance issues.
• Provide guidance to plant personnel on documentation and investigations
• Able to perform tasks with minimal error rate.
• Perform any other tasks/duties as assigned by management.
• Basic knowledge and application of cGMPs and supporting regulatory documents
• We all must embrace the QUALITY culture.

Qualifications and Requirements

• High School Diploma or GED equivalent required. Associates or Bachelor's Degree preferred.

• At least two (2) years of related experience (QA, Compliance, Auditing, Laboratory or Inspection, within a GMP environment) preferred.

• Experience in QA working in a cGMP manufacturing environment (preferred)

• Working knowledge and understanding of quality assurance principles and familiarity with QA programs

• Strong analytical skills, attention to detail and adherence to procedures

• Demonstrated ability to effectively work under dynamic constraints

• Strong organizational, interpersonal and communication skills (oral and written).

• PC Skills Required (MS Word, Excel)

• Ability to work overtime as needed.

Physical Environment and Physical 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.
• Employees must maintain a clean‑shaven appearance each working shift to wear tight‑fitting respirators properly.

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/fmlapost.pdf

• Know Your Rights: [Know Your Rights: Workplace discrimination is illegal (https://linkprotect.cudasvc.com/url?a=https%3a%2f%2fprotect.checkpoint.com%2fv2%2fr01%2f https%3a%2fwww.eeoc.gov%2fsites%2fdefault%2ffiles%2f2023-06%2f22-088_EEOC_KnowYourRights6.12ScreenRdr.pdf.YzJ1Ompqa2VsbGVyOmM6bzpjNjhjZmFmZDNmMjIwNGI4Nzc2YzJiZDM4OTU1YmVjMTo3OjI0ZGI6OGRmZDZjYzU0MjI0ZmQ5NzcwY2UxNWI5Y2Q1NDMyMDQyNzhjYzVlNThkN2ZlMWUyZGQzZTQxMmU0NzVjOWNkMTpoOlQ6Tg&c=E,1,vPNBSNCZkiDYKdJbiUoASO06l2hz5TjOrkElSpCGo6rKM9_UnDDdiUiisVe_u_hDnErnMyZrrYFajU_1WYes4xp8wKLMNsIfkk5lC-byLk&typo=1) eeoc.gov)

• Employee Polygraph Protection Act: https://www.dol.gov/whd/regs/compliance/posters/eppac.pdf

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