QA Operations Supervisor

American Regent, Inc.; New Albany (IN); On-site; USD 65,000 - 90,000; Full time

Job summary

American Regent, Inc. seeks a QA Operations lead to oversee activities at a sterile manufacturing site, reporting to the QA Manufacturing Operations Manager. You will supervise QA Technicians and ensure timely, quality oversight of production operations, including materials receipt, manufacturing and packaging.

The role emphasizes investigating deviations, CAPA coordination, SOP maintenance, and adherence to cGMP and health and safety standards. Strong leadership and communication are essential.

Qualifications

• Associate’s or Bachelor’s Degree in Life Sciences, Business or related field is required.
• Minimum of 2 years of work experience in QA, Regulatory, Compliance or Pharmaceutical Operations in a cGMP environment is required.
• Minimum of 1 year leadership experience required.
• Experience in sterile pharmaceutical manufacturing preferred.
• Extensive knowledge of cGMPs and other regulatory standards for Finished Product manufacturing.
• Demonstrated success in managing multiple activities at the same time and producing outstanding results.
• Excellent organizational, interpersonal and communication skills (oral and written).

Responsibilities

• Supervise QA Technicians to assure timely and quality oversight of daily production activities including materials receipt/release, manufacturing/filling and packaging.
• Lead on-site QA activities in investigating deviations or compliance issues associated with daily manufacturing operations.
• Identify and facilitate the resolution of quality issues including deviations, investigations and CAPA in conjunction with senior QA staff.
• Identify and facilitate quality process improvements to increase efficiencies and performance of systems, operations and personnel.
• Write and revise SOP’s and other GMP documentation.
• Ensure all work is performed and documented in accordance with existing Company policies and procedures, as well as cGMP and health and safety requirements.
• Perform any other tasks/duties as assigned by management.

Skills

Leadership

GMP knowledge

CAPA investigations

Regulatory compliance

SOP documentation

Education

Bachelor's degree in Life Sciences / related field

Associate’s degree (acceptable)

Tools

Job description

Nature and Scope

This position, reporting to the QA Manufacturing Operations Manager, is responsible for leading QA Operations activities at a sterile manufacturing site.

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.

· Supervise QA Technicians to assure timely and quality oversight of daily production activities including materials receipt/release, manufacturing/filling and packaging.

· Lead on-site QA activities in investigating deviations or compliance issues associated with daily manufacturing operations.

· Identify and facilitate the resolution of quality issues including deviations, investigations and CAPA in conjunction with senior QA staff.

· Identify and facilitate quality process improvements to increase efficiencies and performance of systems, operations and personnel.

· Write and revise SOP’s and other GMP documentation.

· Ensure all work is performed and documented in accordance with existing Company policies and procedures, as well as cGMP and health and safety requirements.

· 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.

· Associate’s or Bachelor’s Degree in Life Sciences, Business or related field is required.

· Minimum of 2 years of work experience in QA, Regulatory, Compliance or Pharmaceutical Operations in a cGMP environment is required.

· Minimum of 1 year leadership experience required.

· Experience in sterile pharmaceutical manufacturing preferred.

· Extensive knowledge of cGMPs and other regulatory standards for Finished Product manufacturing.

· Demonstrated success in managing multiple activities at the same time and producing outstanding results.

· Excellent organizational, interpersonal and communication skills (oral and written).

Physical Environment and Requirements

· Physically able to wear cleanroom/protective gowning and equipment, including but not limited to gowning, goggles, face shields, and protective gloves. PPE is 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.

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/fmla.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://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

Alert: We’re aware of individuals impersonating our staff to target job seekers. Please note:

· All legitimate communication will come directly from a verified ARI recruiter either by phone or via an americanregent.com email address.

· Our recruiting process includes multiple in person and/or video interviews and assessments.

· If you are unsure about the legitimacy of a message, contact John Rossini at [e-mail] before responding.

· We never request payment, bank information, or personal financial details during our offer process.

Your security is important to us, and we encourage you to stay vigilant when job searching.

American Regent Inc. endeavors to make https://careers.americanregent.com/ accessible to any and all users. If you would like to contact us regarding the accessibility of our website or need assistance completing the application process, please email [e-mail].