QA Specialist II

Shire Pharmaceuticals - Cambridge, MA (30+ days ago)3.6


Primary Duties

Routine management & coordination of GMP compliance systems and policies for Alewife facility. Monitors policies, processes, procedures and controls ensuring that performance and quality of products conform to established standards and agency guidelines to ensure lasting customer satisfaction. Review of production records for compliance. Assures cGMP’s and company procedures are followed and, if needed, procedures/policies are revised. Accountable for meeting functional area goals and objectives as they relate to departmental and HGT goals. Responsible for adhering to

GMP regulations, cGMP’s, company policies, and DNA leadership capabilities.

  • Must be able to work occasional Weekends.
Responsibilities

60%: Record reviews

40%: Quality System management and improvement

Education and Experience Requirements

A minimum of a B.S. degree in science or engineering with at least 3 years relevant experience executing, developing, and/or administrating GMP quality programs in cGMP biotech and/or pharmaceutical environments.
Excellent interpersonal skills and the ability to communicate well orally and in writing.
Other Job Requirements

Must be flexible to work late shifts and weekends on ad-hoc basis.

Key DNA Leadership Capabilities: proficiency/excellence in all Job Scope 2 capabilities

Accountability & Ownership
Delivering Excellence
Self-Knowledge
Judgment and Decision Making
Energy and Drive