Quality Assurance (QA) Specialist | GenomeWeb

Quality Assurance (QA) Specialist

Organization
Almac Group
Job Location
4204 Technology Drive
Durham, NC 27704
Salary
Competitive
Benefits

Full benefits and generous PTO

Job Description

Almac Group is a group of established businesses at the forefront of the Pharmaceutical industry. Our Company is a recognized global knowledge-based leader for the research, development and delivery of pharmaceutical services. Almac Group's services extend from drug discovery through all areas of clinical trials to the commercialization of pharmaceutical products. Our commitment to Discovery, Development and Delivery in conjunction with our long term partnerships with the majority of the world's leading pharmaceuticals guarantees a secure future for everyone.

Our Diagnostics division (DX) has an exciting opening for a Quality Assurance Specialist to join our talented team and help to support the continuing growth of our business. He/she will be responsible for ensuring compliance with CLIA/CAP certification requirements generated during and in support of the clinical testing service. In particular, to ensure that QA and validation activities are adequately planned, performed, and implemented on a continual basis as required by the company's quality policy and regulatory agencies.

Responsibilities include but are not limited to:

• Create, review and approve policies, procedures, work instructions, protocols and reports to ensure compliance with regulations including CLIA, CAP, and FDA in collaboration with Craigavon Quality and Durham Operations teams
• Review compliance to existing procedures by completion of internal quality audits and make recommendations for improvement where appropriate.
• Review quality control and calibration data to confirm compliance with approved methods and procedures
• Ensure that opportunities for continuous improvement are identified by ensuring that systems such as Corrective Action and Change Control Procedures are maintained, notified, implemented and satisfactorily closed out in accordance with written procedures.
• Maintain metrics for quality systems including: supplier quality, non-conformances, and CAPA
• Ensure that all necessary quality records have been completed and reviewed/approved by responsible personnel
• Day-to-day supervision of the document control system ensuring that the identification, traceability and distribution of approved documents such as SOP's and specifications are controlled.
• Participate in maintenance of the supplier quality program, including create/maintain quality agreements, perform audits per audit schedule and ensure supplier corrective actions
• Support employee training program to ensure effective training and compliance with regulations
• Prepare QA reports, where necessary, on activities assigned by the Head of Quality and/or Director of Operations

Requirements

Bachelor's degree in a biological or clinical laboratory science, or related field
• Master's degree in a biological or clinical laboratory science, or related field preferred
• A minimum of 3 years of experience in a high complexity CLIA laboratory
• Working knowledge of local, state and federal laboratory regulations
• Working knowledge of high throughput genomic technologies
• A minimum of 5 years of experience in a high complexity CLIA laboratory and additional experience working in an IVD environment preferred.
• Experience with managing QA activities across multiple quality system requirements, including operating under CLIA/CAP.
• Experience with managing QA activities across multiple quality system requirements, including operating under both FDA part 820 and CLIA/CAP preferred.

Additional Skills/Qualifications:
• Exceptional organization and time-management skills
• Proven ability to work independently and to analyze and problem solve issues that impact quality
• Strong computer skills (Word, Excel, PowerPoint, etc)
• Excellent oral and written communication skills
• Attention to detail

How to Apply
About Our Organization

Working at Almac Group is exciting, sometimes challenging but always rewarding. Over a period of sustained global growth spanning in excess of 45 years, the diligence and dedication of our 3,700 strong family have made our company the success that it is today. Together we make an invaluable difference to the health of countless patients all over the world - and this is just the beginning!

Be part of something big. Be part of something special. Be part of Almac Group.

Almac Group Ltd. is an Equal Opportunity Employer - Minorities/Women/Protected Veterans/Disabled

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