This position is located in Wilmington, OH.

Position Summary

Alkermes is seeking an experienced individual responsible for supporting the daily manufacturing and facility operations, along with project support. Functions include proactive support of change control assessments, documentation reviews and validation review/support. Functions also include reactive support of discrepancy identification and resolution on the floor, Investigation Team Support, TrackWise (assessing product impact), and reporting operational metrics. This function supports and communicates events to shift leadership on a daily basis.

Qualifications:

· Bachelor's degree in a scientific discipline strongly desired.

· Minimum 2-5 years related experience in a Quality Assurance role in the pharmaceutical industry.

Technical Knowledge/Skills Needed:

· Strong written and oral communication skills.

· Basic introduction / understanding of the regulatory process from development through commercial manufacturing.

· Pharmaceutical Quality Assurance experience, including the ability to identify and resolve compliance issues.

· Familiarization with oral solid dose manufacturing qualification and quality.

· Experience in change management and investigation resolution including Deviation and CAPA systems. Experience with Lab Investigation and Complaint systems is a plus.

· Basic knowledge of US Drug Product GMP requirements and associated guidelines. Knowledge of European Drug Product requirements and guidelines is a plus.

· Demonstrated experience in implementation and administration of quality systems for drug product manufacturing. Experience in drug product development and quality control operations is a plus.

· Project management experience including scheduling, tracking and auditing is desired.

· Active participation on pharmaceutical technology transfer teams and CMC team as required

· Experience with the qualification of facilities, utilities, equipment and processes.

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 and prioritize multiple duties and tasks. Ability to increase others’ knowledge of US end European GMP regulations and guidance. Teacher level knowledge of GMPs. Developing leadership skills with a moderate to high degree of independence and oversight. Demonstrated success with increasing levels of organizational responsibility.

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