Grifols: Center Quality Manager, Dallas, TX
Company: Grifols
Location: Dallas, TX
Job Type: Full-Time
We’re Grifols, a $3 billion plasma manufacturer headquartered in Barcelona, Spain. Founded in 1940 with 11,000 employees worldwide, we’re the largest manufacturer of plasma-derived therapies in Europe and the third largest in the United States. We serve healthcare professionals and patients in over 90 countries, have an unmatched record of product safety, and are the largest plasmapheresis company in the world.
A commitment to Grifols will provide you with a career path that you can build upon and be proud of. Our products make an incredible difference in saving people’s lives and in improving the health and well-being of people around the world and are used in everything from chemotherapy applications to stem cell transplantation, hemophilia, primary immunodeficiencies, and even Alzheimer’s research, all of which depend on blood-derived plasma therapy. In addition, despite our size and scope of operations, our plasma centers pride themselves on our “small company” and “family-like” culture. We’re dedicated to and motivated by our mission of saving lives along with our intense focus on quality and giving back to the community. And a career at Grifols offers stable schedules and day-time hours, an entrepreneurial opportunity to grow into center and potentially regional and general management roles, and a work-life balance that values your time with your family and friends. Grifols also has internal education programs that are certified for continued education credits. So you can expect a fast-paced work environment, defined role structure, and lower-risk protocols.
And that’s just the beginning. . . We also offer benefit-eligible employees and their families full healthcare benefits, including dental, vision, and life insurance as well as a Traditional and/or ROTH 401(k) plan with match. Tuition reimbursement is available, and some of our Academy courses even count for university credit! If you enjoy providing knock-your-socks-off customer service in a fast-paced healthcare environment built around teamwork and trust, then consider furthering your career as an Center Quality Manager and please read on . . .
Responsibilities:
• Independent level of quality inspection and control –ensures center compliance with quality standards and regulations.
• Collaborates with Center Managers to ensure product quality, donor suitability and donor safety.
• Directs and monitors processes and ensures center compliance with all applicable state, federal, and company-designated regulations.
• Ensures that Standard Operating Procedures (SOPs) are properly interpreted, implemented in a timely fashion, and that the staff performs according to all SOPs.
• Interprets and implements processes, regulations and SOPs for quality control and overall regulatory compliance, making independent decisions and modifications as required.
• Oversight of all aspects of internal and external audits including execution (if applicable). This includes documentation, review of and preparation of the response.
• Continuously assesses, promotes, and improves the effectiveness of the quality systems in the donor center through recognition of trends, investigation of failures in the execution of procedures,
direct employee observation and review of center documents.
• Responsible for the personnel functions of the Quality Associate(s) including direction, assignment of work, hiring, development and training, disciplinary actions, termination, maintenance of all personnel records,
management of work schedule and delegation/follow-up of tasks.
• Oversees product and biohazard waste shipments: Ensures shipments meet regulatory specifications and product release requirements; ensures accurate labeling and documentation; and, authorizes final shipment.
• Performs a review of the documentation of unsuitable test results and the disposition of the associated results.
• Works in collaboration with the Center Manager to develop the staff’s knowledge of their job function and how their performance relates to the end product and patient.
• Documents, investigates, and performs root cause analysis for deviations and customer complaints, specifically in how they relate to the safety of the donor and the quality of the product.
Job Requirements
• Bachelor of Science degree or equivalent.
• Certified and proficient in quality and compliance.
• Works toward certification from American Society for Quality to be a Certified Quality Auditor.
• Works toward certification as a Designated Trainer for quality area.
• Typically requires 2 years of related experience in a medical and/or cGMP regulated environment.
• Experience with plasma or whole blood.
• Work is performed in an office and/or a laboratory/manufacturing environment.
• Exposure to biological fluids with potential exposure to infectious organisms.
• Exposure to electrical office equipment.
• Exposure to extreme cold below 32*, miscellaneous production chemicals, moving machinery and production equipment.
• Exposure to high levels of noise on production floor.
• Personal protective equipment required such as protective eyewear, garments and gloves.
• Frequently sits for 6-8 hours per day.
• Repetitive hand movement of both hands with the ability to make fast, simple, repeated movements of the fingers, hands, and wrists.
• Occasionally walks. Occasionally bends and twists neck. Light to moderate lifting and carrying objects with a maximum lift of 35lbs.
• Frequently drives to site locations with occasional travel within the United States.
• Able to communicate complex information and ideas so others will understand; with the ability to listen to and understand information and ideas presented through spoken words and sentences.
• Works independently with little guidance or reliance on oral or written instructions and plans work schedules to meet goals.
• Frequently interacts with others, relates sensitive information to diverse groups.
• Must work with diverse groups to obtain consensus on issues.
• Ability to apply abstract principles to solve complex conceptual issues.
For More Information
There’s much more learn about us, of course, and you can find additional information on our www.grifolsusa.com website. There’s so much to share with you in the recruitment process, and we hope you’re as excited as we are about Grifols Plasma Operation’s potential to save lives and grow careers. Thank you for considering Grifols as your employer of choice.
Note that certain state licensures or certifications may apply. In addition, please understand that you’ll be working in a plasma center, which includes exposure to biological fluids with potential exposure to infectious organisms. Personal protective equipment may be required, which will be provided at the company’s expense.
Work is performed in a plasma center. Exposure to biological fluids with potential exposure to infectious organisms. Exposure to electrical office and laboratory equipment. Exposure to extreme cold below 32*. Personal protective equipment required such as protective eyewear, garments and gloves. Work is performed standing for 6-8 hours per day. Repetitive foot movements, bends and twists neck and waist for 4-6 hours per day. Occasionally walks. Repetitive hand movement of both hands with the ability to make fast, simple, repeated movements of the fingers, hands, and wrists. Ability to make precise coordinated movements, of the fingers to grasp and manipulate objects. Light to moderate lifting of 15-30lbs. Heavy lifting of 30-45lbs. for 2-4 hours per day with a maximum lift of 50lbs. May reach above and below shoulder height. Hearing acuity essential. Color perception/discrimination, near vision and far vision correctable in one eye to 20/30 and to 20/100 in the other eye. Able to communicate complex information and ideas so others will understand; with the ability to listen to and understand information and ideas presented through spoken words and sentences. Performs simple and repetitive tasks that vary little each day by following a set of written or oral instructions/procedures. Maintains work pace to meet production standards.
Apply Now!
Please click on the following link to apply now. Grifols is an Equal Opportunity Employer, and we look forward to hearing from you.
The Grifols Recruitment Team
To apply online, please click here.
An equal opportunity employer, M/F/D/V.
Please reference BioTechPharmJobs.com when responding.
