QA Operations Associate I

American Regent, Inc.; New Albany (IN); On-site; USD 42,000 - 64,000; Full time

Job summary

American Regent, Inc. seeks a Quality Assurance professional to ensure GMP compliance and product quality in assigned areas. You will execute site policies, conduct line clearances, and perform packaging inspections and material releases.

The role requires independent work, strong communication, and the ability to escalate issues per SOPs. Applicants should have a high school diploma or GED, with preferred college degrees and FDA-regulated experience.

Qualifications

• High School Diploma or GED required; Associates or Bachelor’s Degree preferred.
• Minimum 1 year work experience in a FDA regulated environment or similarly regulated area is preferred.
• Must be able to work independently.
• Intermediate skills in Microsoft Word and Excel are required.
• Excellent organizational, interpersonal and communication skills required.
• Ability to take feedback constructively and function in a team-oriented environment.
• Ability to work overtime as needed.

Responsibilities

• Achieve and maintain packaging line and inspection room clearance qualification.
• Conduct accurate verifications and checks as well as accurate process inspections.
• Conduct accurate packaging AQL inspections.
• Identify out of specification product, ensuring segregation and escalation, as required.
• Ensure errors and omissions are resolved according to SOP requirements.
• Ensure all work is performed and documented per company policies, cGMP, health and safety requirements.
• Conduct component and raw material release.
• Conduct chart monitoring and escalation as required.
• Support product shipping activities and perform quality verifications.
• Generate logbooks and sheets/labels.
• Review Bills of Materials.
• Basic knowledge of cGMP and regulatory documents.
• Achieve and maintain clean side and sterile side gowns qualifications.
• Achieve and maintain Class A qualification.
• Perform room, area and equipment clearances.
• Participate in Media Fill and maintain qualification.
• Able to perform tasks with minimal error rate.
• Perform other duties as assigned by management.

Skills

MS Word

MS Excel

Independent work

Communication skills

Teamwork/overtime

Education

High School Diploma or GED

Associate or Bachelor’s degree preferred

1 year FDA-regulated experience

Tools

Microsoft Word

Microsoft 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.

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 packaging line and inspection room clearance qualification
• Conduct accurate verifications and checks as well as accurate process inspections
• Conduct accurate packaging AQL 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
• 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 logbooks and sheets/labels
• Review Bills of Materials
• Basic knowledge of cGMPs and supporting regulatory documents
• Achieve and maintain clean side gown and sterile side gown qualifications
• Achieve and maintain Class A qualification
• Perform room, area and equipment clearances.
• Participate in Media Fill and maintain qualification
• Able to perform tasks with minimal error rate.
• Perform any other tasks/duties as assigned by management.

Education Requirements and Qualifications

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill and/or ability required.

• High School Diploma or GED equivalent required. Associates or Bachelor’s Degree preferred.
• Minimum 1 year work experience in a FDA regulated environment or similarly regulated area is preferred.
• Must be able to do work independently.
• Intermediate skills in Microsoft Word and Excel are required.
• Excellent organizational, interpersonal and communication skills (written and oral) required.
• Ability to take feedback constructively and function in a team oriented work environment.
• Ability to work overtime as needed.

Physical Environment and Requirements

• 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.

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

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/f__

• 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://www.eeoc.gov/sites/default/files/2023-06/22-088_EEOC_KnowYourRights6.12ScreenRdr.pdf YzJ1Ompqa2VsbGVyOmM6bzpjNjhjZmFmZDNmMjIwNGI4Nzc2YzJiZDM4OTU1YmVjMTo3OjI0ZGI6OGRmZDZjYzU0MjI0ZmQ5NzcwY2UxNWI5Y2Q1NDMyMDQyNzhjYzVlNThkN2ZlMWUyZGQzZTQxMmU0NzVjOWNkMTpoOlQ6Tg,c=E,1,vPNBSsNCZkiDYKdJbiUoASO06l2hz5TjOrkElSpCGo6rKM9_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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