Compliance Specialist

Talecris Plasma Resources, with over 50 plasma collection centers located in multiple states throughout the US, specializes in the collection of human plasma used in therapies that help people everywhere maintain and enhance their quality of life. We are seeking a Compliance Specialist for our Research Triangle Park, NC facility.

COMPLIANCE SPECIALIST

 

Thoroughly versed in quality control principles and cGMPs, the selected candidate will be responsible for developing and integrating new/revised SOPs as related to the IIR processes, and ensuring compliance  by tracking and trending IIRs as related to deficiencies in SOPs. Primary functions also include contributing to the center audit process and helping avoid the repetition of audit findings and observations throughout the system; working with Donor Center and TRP personnel to facilitate verification of potential compliance issues; Investigating and proposing corrective actions; monitoring and trending IIRs, nonconformance complaints and activities; and ensuring completeness of documentation and internal investigation reports. Assisting in the development of a system-wide CAPA Plan and training materials is among this position’s other duties.

 

Qualified candidates will have:

–  Bachelor’s degree in an allied science discipline (chemistry, biology or medical technology) or work/education equivalent

–  At least 5 years’ experience in biologics/drug manufacturing in an FDA regulatory laboratory facility

–  Demonstrated expertise in cGMPs, FDA regulations and SOP implementation

–  Thorough knowledge of quality control principles and QA audit functions

–  Availability for 50% travel



We offer a competitive compensation and benefits package. To apply and learn more, visit: http://www.talecrisplasma.com and search for job ID # 2336. Indicate salary requirements. No phone calls or agency referrals, please. EOE M/F/D/V