Plasma Regional Quality Managers

Plasma Regional Quality Managers

Talecris Plasma Resources is proud to announce that due to growth initiatives through market expansion, we are now hiring for Plasma Regional Quality Managers.

Job Description:

· Ensures the centers within their respective region Donor Centers are performing in optimal Quality Compliance in regards to Good Manufacturing Practices (cGMP), FDA, and are Talecris Plasma Resources Compliant

· Responsible for ensuring adherence to Standard Operating Procedures (SOP) for Technical Services

· Streamline and simplify GMP operating procedures at the user level

· Develop and integrate new/revised SOPs

· Assure compliance with SOPs upon implementation

· Quality Assurance Audits and Proficiency

· Coordinate audits and report findings to the Director, QA Licensed Centers

· Participate in the center audit process

· Interact with Donor Center and appropriate Talecris personnel to facilitate corrective actions for inspection findings

· Implements CAPA as needed to insure continued quality compliance, Incident Error / Nonconformance Reports and Customer Complaints

· Evaluate adequacy of corrective actions and completeness of reports

· Investigate and propose additional corrective actions as required

· Monitors compliance of corrective actions where indicated

· Monitor and trend customer complaints and nonconformance

· Assist in development of CAPA Plan and related checks

· Support the company training goals through development of training materials for SOPs or other training initiatives as determined by the Talecris Management

· Will provide direct supervision to the center Quality Specialist (QS)

· Provide indirect supervision to the Center Manager related to QA compliance in the Donor Center

· Communicate with Regional Manager where necessary on Donor Center compliance issues

· Assist with the training of center quality standards

· Monitor center and quality performance through direct and indirect contact, which includes periodic on-site visits

· Support the center's ongoing quality training and education through in-service sessions

· Train new employees as necessary as well as update training requirements of current employees

· Must maintain a Designated Trainer Certification in Quality

Job Requirements:

· Must have experience in managing multi site operations / territories, including proven excellence in remote management, and communication skills.

· Previous experience should demonstrate expertise (or knowledge) in cGMP's, FDA regulations, SOP's, as well as an understanding of quality control principles and QA audit functions within a plasma center, blood bank or equivalent medical or regulated field required.

· Requires BA/BS degree in one of the allied sciences (chemistry, biology, medical technology) or equivalent job experience with and applicable degree

· Minimum five (5) years experience in biologics/drug manufacturing or FDA regulated laboratory facility

· Relevant experience (at least 5 years in Quality Assurance) may be substituted for degree requirement, but at least 2 years of college required with the approval of the Chief Operating Officer

· Previous experience should demonstrate expertise in cGMP's, FDA regulations, SOP implementation, as well as an understanding of quality control principles and QA audit functions

Please forward your resume with the job title in the subject line as a text or word attachment to careers@talecris.com No online applications please. We do not accept phone calls or agency referrals. Talecris Plasma Resources offers a competitive compensation & benefits package. Our website will be coming soon. In the meantime, please visit the website of our sister company Talecris Biotherapeutics at www.talecris.com Talecris is proud of its work/life/balance initiatives. We have the expertise, resources & established business infrastructure to develop, manufacture & market biotechnology products internationally. An Equal Opportunity Employer M/F/D/V, Talecris Plasma Resources is committed to enhancing & maintaining cultural diversity within our work environment.