Senior Quality Assurance Specialist

Senior Quality Assurance Specialist

Job Number: 20135509

Location: Beltsville, MD

Country: United States

Date Posted: 1/8/2024

Type: Full time

Employment Type: Regular

Responsibilities

• Primary focus in the role is to deliver QA support for the review and approval on all operational documentation as it relates to the technical transfer project such as protocols, validation documents, etc. This role will be accountable to the technical transfer leadership team while executing tech transfer projects
• Travel to other PET manufacturing sites network-wide to provide quality review of technical transfer projects when required
• When not supporting technical transfer projects, candidate will be responsible for all other quality functions at the PET manufacturing site, such as:
  • Handles cGMP documentation review related to product release, facilities and equipment, material controls, laboratory controls, packaging and labeling, and production & process controls
  • Establishes and reports metrics related products and processes as deemed necessary by the Regional Quality Manager (RQM)
  • Ensures the site manufactures products to meet the requirements of 21 CFR 212 (cGMP)

Qualifications

• Bachelor’s degree in related science field (Microbiology, Chemistry, Biology, Physics) preferred, or equivalent work experience
• 2+ years of experience in related science field preferred
• 1-2 years of experience in Quality Assurance and/or regulated environment highly preferred – cGMP
• Pharmaceutical or medical device experience a plus
• Effective written and verbal English communication skills
• ISO experience a plus

Anticipated salary range: $74,500 - $101,100

Bonus eligible: No

Benefits: Cardinal Health offers a wide variety of benefits and programs to support health and well-being.

Application window anticipated to close: 2/20/2024 *if interested in opportunity, please submit application as soon as possible

Candidates who are back-to-work, people with disabilities, without a college degree, and Veterans are encouraged to apply.

Cardinal Health supports an inclusive workplace that values diversity of thought, experience and background. We celebrate the power of our differences to create better solutions for our customers by ensuring employees can be their authentic selves each day. Cardinal Health is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, ancestry, age, physical or mental disability, sex, sexual orientation, gender identity/expression, pregnancy, veteran status, marital status, creed, status with regard to public assistance, genetic status or any other status protected by federal, state or local law.