Sr. Quality Associate I
Alkermes, Inc. - Wilmington, OH

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Job Description: This position is responsible for performing and/or leading internal audits and supplier audits to assure compliance to internal procedures, policies, and standards, as well as all relevant State, Federal and International regulations. Identifies compliance risks and develops sound rationale as basis for audit observations. Authors Quality Metric Reports and Annual Product Review reports. P articipates in the review and revision of Compliance-related controlled documents. Supports the coordination activities and assists with interactions during regulatory agency inspections. Works on assignments that are semi-routine in nature. Receives general instructions on routine work and more detailed instruction on new assignments.

Minimum Education & Experience Requirements: Prefer a Bachelor’s degree in a scientific discipline or equivalent. Minimum of 5 years’ experience in a Quality Assurance role in the pharmaceutical industry. CQA highly desirable.

Knowledge/Skills Needed: Extensive (teacher level) knowledge of US Drug Product cGMP requirements and associated guidelines. Experience in Pharmaceutical Quality Assurance, including the ability to identify and resolve compliance issues. Ability to increase others knowledge of US and European GMP regulations and guidance. Strong written and oral communication skills. Experience in administration of quality systems for drug product manufacturing and quality control operations.

Personal Attributes Needed: Team Player committed to quality; motivated self-starter; detail and results oriented; Well organized, efficient worker with good communication skills; innovative thinker and problem solver; flexible and can embrace change; can manage multiple duties and tasks. Ability to utilize knowledge and interpersonal skills to provide leadership, direction and development of others. Good computer skills. Good work ethic, dependable, punctual, and flexible. Good motivator of personnel. Can get things done on the basis of influence. Can work in a fast-paced environment with multiple issues. Identifies opportunities to improve and contributes to problem solving.