Job Description
Our client, a global leader in pharmaceutical manufacturing, is seeking a QA Associate to join their operations team. This will be a long term contract assignment of 12-18 months.
Pay Range : $25-30 / hr
Terms : 12-18 month contract
Job Description This function is responsible for disposition of bulk product and release of raw materials. Functions include document review, TrackWise reporting, hold form review, discrepancy tracking, status reporting, resolution and escalation of raw material delays.
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 related tasks. Applies job related skills and understanding of policies and standards in completing tasks.
Key Duties :
- Evaluation of raw material records and testing records
- Disposition of raw materials and bulk batches per associated specifications.
- Approve and / or author intermediate level written procedures and other documents
- Interact with plant personnel to insure CGMP compliance.
- Provides back up for other QA and plant site personnel as appropriate.
- The monitoring of compliance with the requirement of GMP
- Ability to excel in a team environment
Preferred Skills / Abilities :
Working knowledge of US Drug Product GMP requirements and associated guidelinesExperience in Pharmaceutical Quality Assurance, including the ability to identify and resolve compliance issuesAbility to increase others knowledge of US end European GMP regulations and guidanceStrong written and oral communication skillsExperience in administration of quality systems for drug product manufacturing and quality control operationsPreferred 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 tasksAbility to utilize knowledge and interpersonal skills to provide leadership, direction and development of othersGood computer skillsGood work ethic, dependable, punctual, and flexibleGood motivator of personnelGood team player with a can-do attitudeCan get things done on the basis of influenceCan work in a fast-paced environment with multiple issues open simultaneouslyHighly organizedAttention to detailIdentifies opportunities to improve and contributes to problem solvingRequired Education / Experience :
Bachelor’s degree in a scientific discipline or equivalent2+ years relevant experience in a Quality Assurance role in the pharmaceutical industryWorking knowledge of US Drug Product GMP requirements and associated guidelines