QA Operations Supervisor

American Regent, Inc.; New Albany (OH); On-site; USD 90,000 - 120,000; Full time

Job summary

American Regent, Inc. seeks a QA Operations Manager to lead QA operations at a sterile manufacturing site.

This role reports to the QA Manufacturing Operations Manager and focuses on supervising QA Technicians, guiding investigations of deviations, CAPAs, and regulatory compliance during daily production. Requirements include a Life Sciences or related degree and at least 2 years in QA/regulatory/pharma operations in a cGMP environment, plus 1 year of leadership.

Qualifications

• Bachelor’s or Associate’s degree in life sciences, business or related field.
• Minimum 2 years in QA, regulatory, compliance or pharmaceutical operations in a cGMP environment.
• Minimum 1 year of leadership experience.

Responsibilities

• Supervise QA Technicians to oversee daily production activities including materials receipt/release, manufacturing and packaging.
• Lead on-site QA activities in investigating deviations or compliance issues.
• Identify and facilitate resolution of quality issues including deviations, investigations and CAPA with senior QA staff.
• Identify and facilitate quality process improvements to increase efficiencies.
• Write and revise SOPs and other GMP documentation.
• Ensure all work complies with company policies, cGMP and health and safety requirements.
• Perform other tasks as assigned by management.

Skills

Leadership experience

Quality oversight

GMP knowledge

Regulatory knowledge

Communication skills

Problem solving

Education

Associate’s or Bachelor’s Degree in Life Sciences, Business or related field

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

PPE is essential for the health and safety of employees.

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/fmlaposter.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

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].

Our values define who we are. They are the fundamental beliefs of our organization and guide our actions and behavior. They influence the way we work with each other, the way we serve our clients, and the way we engage with our communities. Supporting patient health and enhancing the quality of life for animals are our guiding principles. Our promise is to provide the healthcare marketplace with a steady supply and broad portfolio of branded and generic specialty injectables.

American Regent, Inc., a Daiichi Sankyo Group Company, is a top-10 injectable manufacturer. For over 50 years, we have been developing, manufacturing, and supplying high-quality generic and branded injectables for healthcare providers and veterinarians across the United States and Canada.

For 20 years, American Regent has been a leader in IV iron therapy and we supply two of the top-selling brands in the US today.

For over 30 years, we have supplied the leading joint health products for horses and dogs.

We have locations in New York, Ohio, and California and sales territories nationwide.