QA Associate I/II - 3rd Shift

Alkermes • Wilmington, OH

70d

About The Position

This function is responsible for supporting the daily on the floor activities related to the manufacturing operations. Functions include area clearances, on the floor batch record review, discrepancy identification, logbook review, status tagging, TrackWise Triage, room/utility checklists, 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.

Requirements

• High school diploma
• 2+ years' experience in a Quality Assurance role in the pharmaceutical industry
• 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 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
• Good computer skills
• Good work ethic, dependable, punctual, and flexible

Nice To Haves

• 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
• Good motivator of personnel
• Good team player with a can-do attitude
• Ability to 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

Responsibilities

• 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 ensure CGMP compliance
• Prepare and maintain batch data tables for trend analysis
• Provides back up for other QA and plant site personnel as appropriate
• Monitor compliance with the requirement of GMP

What This Job Offers

• Industry: Chemical Manufacturing
• Education Level: High school or GED