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Quality Assurance Associate I

Job ID: 7008
Location: Wilmington, OH
# of Openings: 1


Quality Assurance Associate I

Alkermes, Inc. is a fully integrated, global biopharmaceutical company that applies its scientific expertise and proprietary technologies to develop innovative medicines that improve patient outcomes. The company has a diversified portfolio of more than 20 commercial drug products and a substantial clinical pipeline of product candidates that address central nervous system (CNS) disorders such as addiction, schizophrenia and depression.  Headquartered in Dublin, Ireland, Alkermes has an R&D center and US headquarters in Waltham, Massachusetts and manufacturing facilities in Athlone, Ireland, and Wilmington, OH.  For more information, please visit Alkermes’ website at .





This function is responsible for supporting the daily on the floor activities related the manufacturing operations and quality systems.  Functions include area clearances, on the floor batch record review, discrepancy identification, logbook review, status tagging, TrackWise Triage, room/utility checklists, complaints, document control and product shipping. This function thresholds events to Senior Associate when they are outside of the area of responsibility


The position will perform general QA work, using their ability as a skilled contributor in completing tasks where judgement is required in resolving problems and making recommendations.  Works on problems of a diverse scope where analysis and problem solving is required.  Receives general oversight and guidance on approaches to complete project related tasks.  Applies job related skills and understanding of policies and standards in completing tasks.


Key Duties:


  • Authority to approve written procedures and other documents
  • Develop Standard Operating Procedures and other quality related documents.
  • Evaluation of batch manufacturing records and testing records
  • Follow-up on preventive and corrective actions associated with deviations, lab investigations and Environmental Excursions
  • Interact with plant personnel to insure CGMP compliance.
  • Prepare and maintain batch data tables for trend analysis
  • Provides back up for other QA and plant site personnel as appropriate.
  • The monitoring of compliance with the requirement of GMP
  • Investigate complaints


Skills / Abilities:


  • Working knowledge of US Drug Product GMP 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 end 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.
  • Strong written and oral communication skills.




  • 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.
  • Good team player with a can-do attitude.
  • Can get things done on the basis of influence.
  • Can work in a fast-paced environment with multiple issues open simultaneously.
  • Highly organized.
  • Attention to detail.
  • Identifies opportunities to improve and contributes to problem solving.




  • Requires a Bachelor’s degree in a scientific discipline or equivalent experience.




  • 0-2 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, disability, genetic information, veteran status, military status, application for military service or any other class protected by state or federal law.

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