This position is responsible for carrying out T-SPOT® assays and other processes during validation of procedures, QC of finished product and raw materials, and to support the Quality Manager in the running of the Quality Management System and general administration of documentation for the QMS. This will include the following:
Overall responsibilities:
1. Maintenance of reference material, including cell culture and stock validation
2. QC of raw materials, incoming goods and any product manufactured by Oxford Immunotec
3. QC of manufactured products and assembled kits
4. Validation of procedures, equipment and software
5. Planning and conducting of stability testing procedures
6. Performing other laboratory testing as required
7. Maintaining the equipment databases to ensure all equipment is calibrated, maintained and serviced as required
8. Assisting with the control of Quality Management system documentation
9. Assisting with the preparation of further documentation for the Quality Management system
10. Assisting with the monitoring of compliance with the QMS and with tracking systems associated with CLIA, CAP, State requirements, ISO 13485:2012, ISO 9001:2008 and ISO 17025:2005 and the QSR
11. Assist the Quality Manager to ensure the continuing effectiveness of the QMS
12. Assist during internal and external audits
13. Conduct laboratory spot check audits
14. Assist with the QA review of documentation including non-conformances, CAPAs and complaints
15. Perform miscellaneous duties as necessary and requested by the Quality Manager
Specific deliverables for the role are:
1. Contributing towards the maintenance of the quality of the Company’s products in fulfillment of the Company goals
2. Control and conduct of product stability testing to support expiry dates and shipping claims
3. Monitoring of product conformity through archive kit testing
4. Assisting with ensuring compliance in the manufacturing process and documentation
5. Ensure that areas of responsibility do not contribute to any major non-conformance during external audits for GMP, ISO 13485:2003, ISO 17025:2005 and ISO 9001:2008
6. Regular communication with QA/QC team members and other functional groups to provide QC and validation support for both Process and Design controls
7. Working to Oxford Immunotec’s Company Values at all times.
8. Follows all company safety policies & other safety precautions within work area
9. Regular attendance and timeliness is essential
QUALIFICATIONS:
• Bachelor’s degree, or college education and equivalent experience
• 5+ years Quality experience, preferably in laboratory or medical device environmen
***Must have cell culture experience***
• Good working knowledge of MS Office
• Experienced in working to GLP and Quality Management principles
• Strong attention to detail and Quality commitment
• High standards of mathematics and writing ability
• Conscientious, thrives in high pressure work, and demonstrates strong initiative
PHYSICAL DEMANDS:
The physical demands described within the Position Responsibilities section of this job description are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is regularly required to be independently mobile. The employee is also required to interact with a computer, and communicate with peers and co-workers. Minimal travel required including international travel. Job requires employee to walk considerable distances in the facility during the course of his or her work.
Job details are sourced from the employer's original posting.
Open job postingAbout the company
Integrated Resources, Inc is a premier staffing firm recognized as one of the tri-states most well-respected professional specialty firms. IRI has built its reputation on excellent service and integrity since its inception in 1996. Our mission centers on delivering only the best quality talent, the first time and every time. We provide quality resources in four specialty areas: Information Technology (IT), Clinical Research, Rehabilitation Therapy and Nursing.