Position : Quality Laboratory Systems Specialist

Location : Research Triangle Park, NC

Duration : 12 Months

Total Hours/week : 40.00

1^st Shift

Client: Medical Device Company

Job Category: Quality

Level Of Experience: Mid-Level

Employment Type: Contract on W2 (Need US Citizens Or GC Holders Or OPT EAD)

Must Have:

• Data review of laboratory data and we would prefer experience in data review related to HPLC, LCMS, GCMS, ICPMS instrumentation (analytical equipment). If they were strong in the above instrumentation and had some experience even peer reviewing that might work.

Job Description:

• This position will function within the Quality Assurance Unit of Corporate Preclinical Development and Toxicology and will participate in the conduct of nonclinical laboratory investigations of medical devices and materials in accordance with GLP regulations and the client CPDT Quality System.
• Quality Assurance strives to live client values as part of an action-oriented team focusing on customer requirements and process effectiveness through continuous learning, influencing of others, and dedication to achieving the highest quality results.
• The Quality Systems Specialist II is accountable for support of the continued development, improvement and implementation of the Quality Systems.
• This position actively participates in quality guidance, product resolution decisions and problem solving techniques to promote New Product Development and provide support to project teams for process improvement and continuous improvement activities.

Responsibilities:

• Responsible for utilizing and developing 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.
• Quality Assurance Unit documentation/activity support applies to most aspects of the systems employed by client CPDT for material risk assessments, material characterization, and internal/external GLP biocompatibility testing for medical devices as described in ISO 10993 and FDA G95-1.
• Active Participation in the development, implementation and maintenance of various aspects of the client CPDT Quality System including creating and reviewing documents (SOPs, Procedures, Methods, Protocols) in overall support of continual quality improvement.
• Support the client CPDT Training System in order to ensure training is performed and documented in order to maintain compliance to Quality System and regulatory requirements.
• Support the client CPDT Document Control system for all controlled documents including but not limited to Policies, Protocols, Reports and Standard Operating Procedures.
• Accompany representatives from sponsoring organizations or government regulatory agencies during site audits.
• Responsible for GLP, ISO and Quality System training.
• Responsible for maintaining the Master Schedule.
• Serve as backup for the client CPDT GLP Archives for all controlled records, documents and samples.
• Assist with Metrology program including maintenance of Regulatory Asset Manager System.
• Assist in management of the supplier audit and approval system, including setting audit dates with suppliers and performing audits.
• 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.