Quality Management Rep
Mentor, OH
Req ID 50859BR
Business Title
Quality Management Rep
Business
Global Quality
Sub-Business
BioScience BioLife Support
Country
US
State/Province
Ohio
Location of Position
Mentor, OH
Shift_
1st
Job Description
""Monitors all systems and activities to ensure that source plasma manufacturing is performed consistently according to current Good Manufacturing Practices (cGMP), the Baxter Quality System, and other applicable regulations for a plasma center producing approximately 40,000 liters per year. Authorized and responsible to cease operations within the center or stop source plasma shipment(s) if product or donor safety is or may be compromised.
•Stays current with federal, state, local and company-specific rules, regulations, and practices.
•Ensures center compliance with all federal, state, local and company-specific regulations related to quality of product, employee and donor safety.
•Reviews records to ensure they are complete, accurate and compliant with cGMP requirements. Records include all operational documents (donor history and medical cards, equipment calibration and maintenance, employee training, laboratory test results, packaging, inventory, shipment, etc.) involved in the processing and shipment of plasma as it relates to donor, employee and product safety.
•Tracks deviations in operating procedures and policies through established mechanisms. Reports errors, deficiencies, discrepancies and observations to center management and Regional Quality Management Representative. May stop operations or shipments when donor or product safety is or may be compromised.
•Works in collaboration with Facility Manager and management team to prepare for and host (if needed) internal and external auditors. Assists center management teams to ensure timely closure of audit observations.
•Tracks responses to and corrective action for exception variances, error and accident reports, and post-donation information reports.
•Conducts monthly quality assurance audits for critical control points and key elements for the systems related to donor suitability, source plasma collection, sample collection, plasma storage, product release, quality assurance, tetanus immunizations and employee training and competency assessment.
•Initiates SOP revisions as needed to support continuous improvement.
•Ensures that SOP's are current and validated and that staff perform routine tasks according to SOP through direct observation.
•Ensures that required validation protocols are performed and reported according to established guidelines.
•Coordinates management review meetings and participates in center staff meetings.
•May be responsible to support and conduct QMR training, in addition to other projects as assigned by Regional Management Representative.
•Other duties and responsibilities as assigned. Supports the center management team in identifying operational opportunities for continuous improvement, initiating changes to center processes as needed, through use of company approved procedures (including but not limited to 5S, Value Stream Mapping and Kaizen).
Office/Production environment. May require weekend and extended work periods. May assist in center operations, as needed which requires bending, stooping and lifting up to 50 pounds. Potential exposure to blood borne pathogens.""
Job Requirements
""Bachelors degree and a minimum of one year relevant work experience, or an equivalent combination of education and experience. Relevant work experience within medical or regulated field, highly desirable. Previous work experience within the plasma collection industry is strongly preferred.
Computer skills in word processing, spreadsheets and databases highly desirable. Demonstrated understanding of quality assurance in an FDA-regulated environment. Demonstrated understanding of plasma center operations. Effective organizational, technical and problem solving skills.""
Doing Work that Matters
Baxter provides its employees with comprehensive compensation and benefits. To view additional opportunities at Baxter and to learn more about the company, please visit our Web site at company website. EOE M/F/D/V.
