Job Title: Quality Control Specialist
This is a career opportunity for a Quality Control Specialist to work in a regulated environment.
Key Responsibilities:
* Timely review of data generated to support batch release and stability programs.
* Experience with Empower is essential, with good attention to detail and the ability to prioritize workload effectively.
* Familiarity with checking results against trend limits and specifications, identification of deviations, and lab investigations.
* Trending of data for quality control purposes.
* Tracking and identification of not right first time (NRFTs) events.
* Support to the QC Laboratory and Management teams.
* Effective interaction with other departments on raw materials, intermediates, and finished batch releases.
* Closely maintained contact with the Quality Compliance Specialists and QC team Leaders.
* Maintenance, update, and issuance of control prints, methods, specifications, and SOPs in compliance with pharmacopeial and regulatory requirements.
* Assistance with training of analysts in areas of expertise and knowledge and new methods, SOPs, and updates.
* Excellent Communication skills.
* Initiative – ability to work independently and see issues through to completion.
* Prioritization of work and effective teamwork.
* Extensive knowledge of cGMP and GDP in a regulated environment.
* Working knowledge of quality systems in a regulated environment.
* Accuracy and attention to detail.
* Interpersonal skills.
Benefits: Competitive salary, comprehensive benefits package, and opportunities for professional growth and development.