Quality Assurance Manager

Integrated Resources, Inc ( IRI ); Swiftwater (Monroe County); On-site; USD 80,000 - 110,000; Full time

Job summary

An established industry player is on the lookout for a Quality Assurance Manager to oversee critical quality processes within the pharmaceutical sector. This exciting role requires a blend of technical expertise and leadership skills, ensuring compliance with quality regulations while managing CAPA activities. The ideal candidate will thrive in a fast-paced environment, demonstrating strong communication abilities and a keen attention to detail. Join a dynamic team where your contributions will directly impact the quality of life-saving products and drive innovation in the biopharmaceutical field.

Qualifications

• 6-9 years of experience in the pharmaceutical/biopharmaceutical industry.
• Strong knowledge of Quality System Regulations and CAPA activities.

Responsibilities

• Lead quality review for documents and investigate deviations.
• Interface with cross-functional teams and manage multiple projects.

Skills

Quality System Regulations

CAPA activities

Communication skills

Detail-oriented

Project management

Education

Bachelor's Degree in engineering or technical discipline

Master's Degree

Job description

Job Description:

Integrated Resources, Inc (IRI) is seeking a Quality Assurance Manager with the following qualifications:

• Bachelor's Degree/Undergraduate Degree in engineering or technical discipline.
• Master's Degree preferred.
• Experience in pharmaceutical/biopharmaceutical industry or related industry/manufacturing environment. Background in life science is a plus.
• Strong working knowledge of Quality System Regulations.
• Experience leading CAPA (Corrective and Preventive Action) activities.
• Quality review for documents associated with protocols, functional specs, detail design specs, site acceptance tests, and data packs.
• Investigate deviations and serve as the final approver on such documents.
• Ability to work on strict deadlines and interface with cross-functional teams.
• Detail-oriented with the ability to handle multiple projects concurrently.
• Well-developed communication skills, both verbal and written.
• Years of Experience: 6 - 9 Years.
• Experience in Bulk Formulation and Aseptic Filling preferred.

Seniority Level

Mid-Senior level

Employment Type

Contract

Job Function

Quality Assurance and Other

Industries

Pharmaceutical Manufacturing, Biotechnology Research, and Medical Practices