QA Associate III at Alkermes, Inc. in Wilmington, Ohio

Job Description:

QA Associate III

This function is responsible for supporting the daily manufacturing and facility operations of the Development and External Operations teams and Alkermes' Contract Manufacturers (CM). Functions include cross functional team membership from a quality operations perspective (Supply Chain, EH&S, Technical Operations, etc.), CM batch record review / approval, CM document review / approval, discrepancy review / approval, and CM on-site support. This function communicates events to Manager daily and thresholds events to when they are outside of the area of responsibility.

Key Duties:

• Authority to approve or reject written procedures, batch records, specifications, and other documents for the Development and External QA team or contract manufacturer.


• Evaluate routine deviations / investigations and manage through to closure under guidance from manager.


• Implements and maintains quality assessment for change controls both internal to Alkermes and in support of Alkermes CM's.


• Participates in the approval and monitoring of contract manufacturers (clinical packaging CMO support).


• Supports Development and External Operations teams and CM support by providing quality support to projects and ensuring cGMP compliance.


• Identification of initiatives to improve work practices within own team and reporting same to manger, implementing where appropriate.


• Perform SOP updates / revisions and author new procedures as they relate to quality.

Preferred Skills / Abilities:

• Experience in Pharmaceutical Quality Assurance, including the ability to identify and resolve compliance issues.


• Experience in pharmaceutical product development environment and an understanding of expectations for early and late phase clinical trials.


• Working knowledge of US and European Drug Product GMP requirements and associated guidelines.


• Experience in administration of quality systems for drug product development, manufacturing and quality control operations.

Preferred Personal Attributes:

• 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.


• Can get things done on the basis of influence.


• Ability to increase others knowledge of US end European GMP regulations and guidance.


• Strong written and oral communication skills.


• Attention to detail.


• Has a thorough understanding of the regulatory process from GLP through commercial manufacturing.


• Teacher level knowledge of GMP's.

Required Education / Experience:

• Bachelor's degree in a scientific discipline or equivalent.


• Minimum of 4 years' experience in a Quality Assurance role in the pharmaceutical industry.

Alkermes, Inc. is an equal employment opportunity employer and does not discriminate against any applicant because of race, creed, color, age, national origin, ancestry, religion, gender, sexual orientation, gender expression and identity, disability, genetic information, veteran status, military status, application for military service or any other class protected by state or federal law. Alkermes also complies with all work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Alkermes is an E-Verify employer.

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Experience Level:
Associate

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