Job Overview
This position is responsible for ensuring the quality of products by reviewing data, conducting laboratory investigations and trending of data.
Key Responsibilities:
* Review data generated in a timely manner to support batch release and stability programs.
* Experience with Empower is essential. Good attention to detail, ability to take ownership and prioritize workload for deadlines.
* Familiar with checking results against trend limits and specifications, identify deviations and/or lab investigations.
* Trending of data, track and identify not right first time (NRFTs) events.
* Support the Quality Control Laboratory and Management.
* Effective interaction with other departments on matters related to raw materials, intermediates and finished batch releases.
* Maintain, update and issue control prints, methods, specifications and Standard Operating Procedures (SOPs) in compliance with pharmacopeial and regulatory requirements.
Requirements
Skills and Qualifications:
* Extensive knowledge of current Good Manufacturing Practices (cGMP) and Good Distribution Practices (GDP) in a regulated environment.
* Working knowledge of quality systems in a regulated environment.
* Excellent accuracy and attention to detail.
* Excellent interpersonal skills.
* Empower experience is essential.
Benefits
We offer a competitive compensation package including a 12 month contract.
Others
The ideal candidate will have excellent communication skills and be able to work in a self-directed manner to see issues through to completion.