The pharmaceutical Quality Control Representative provides primary support for parenteral products production. Has responsibility for maintaining quality systems and ensuring GMP compliance. Provides guidance with regard to deviation investigations, change management, master document revision, and process/product validation. Provides final product disposition for all lots manufactured within the site and provides quality system coaching/mentoring to operations personnel. Position is essential for maintaining GMP compliance.

Position Responsibilities:

Responsible for approving the final product following its manufacturing and filling by completing a detailed audit of the manufacturing and supporting documents. Other tasks include publishing Certificates of Analysis, investigating out of specification results, and reviewing control charts. Also responsible for maintaining compliance with the stability requirement outlined in applicable product registrations.

Provides QC support to the manufacturing and filling operations devoted to coaching on quality systems, increasing technical expertise in the manufacturing/filling process, solving problems, performing in-process document audits, and serving as a resource for issue resolution. Participates in cross-functional teams with Technical Services, Engineering, and Production that focus on areas such as daily production operations, planning and process improvement.

Responsible for reviewing GMP documents (e.g., master formulas, procedures, change proposals, manufacturing ticket inserts). Responds to deviations by assessing the impact on product safety, identity, strength, purity and quality (SISPQ) and coordinating the investigations. Reviews and approves change proposals and qualification documents to ensure that processes remain in a validated state and within regulatory commitments. Responsibility for reviewing a Periodic Product Quality Evaluation which critically evaluates any trends and quality issues. May lead or participate on task teams to improve or streamline the Quality Systems. Direct contact with officials from regulatory agencies (e.g., FDA, MCA) is occasionally necessary to verify compliance with various commitments. Responsible for the investigation of product complaints submitted by Consumer Technical Services. This includes a detailed batch review process, root cause determination, and recommendation for eliminating complaints.

Provides support to the production process teams. This support can consist of consulting on quality and GMP issues as well as training operators and support staff on quality systems.

Requirements:

Bachelor's degree or equivalent experience in a science-related field.

Demonstrated strong written and verbal communication skills.

Demonstrated excellent interpersonal and networking skills.