Quality Assurance Specialist
2 days ago
This position will support the Quality Assurance Unit of Corporate Preclinical Development and Toxicology in the conduct of nonclinical laboratory investigations of medical devices and materials in accordance with GLP regulations and the client CPDT Quality System.
The Quality Systems Specialist II will be responsible for the development, improvement, and implementation of the Quality Systems, including creating and reviewing documents (SOPs, Procedures, Methods, Protocols) in overall support of continual quality improvement.
Key Responsibilities:
Develop and implement phase and systems audit programs for internal laboratory functions and external suppliers in direct support of 21 CFR Part 58, ISO 17025, and the overall Quality System.
Provide support for the client CPDT Training System to ensure training is performed and documented in order to maintain compliance to Quality System and regulatory requirements.
Assist with Metrology program including maintenance of Regulatory Asset Manager System.
Collaborate with managers, scientists, and Quality Assurance personnel to develop process improvements in order to enhance testing and workflow efficiency.
Maintain an environment of continuous improvement and quality aligned with client core values and strategic objectives.
Requirements
Strong knowledge of GLP regulations and quality systems.
Experience in data review related to HPLC, LCMS, GCMS, ICPMS instrumentation (analytical equipment).
Ability to develop and implement quality systems and audit programs.
Strong communication and collaboration skills.
Ability to work in a fast-paced environment and prioritize multiple tasks and responsibilities.
What We Offer
MILLENNIUMSOFT offers a competitive salary and benefits package, as well as opportunities for professional growth and development.
We are an equal opportunity employer and welcome applications from diverse candidates.
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