Quality Specialist I : DLMP Job

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Location ROCHESTER, Minnesota
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Quality Specialist I : DLMP Job - Department: DLMP : Human Cell Therapy

A Life:Changing Career


Responsibilities: Works with the management team to ensure the quality system essentials are in place for all assigned areas. Responsible for developing and maintaining the quality program for the laboratory/work unit in collaboration with management team. Represents the laboratory in all accreditation inspections and oversees the proficiency testing program.

Qualifications: Bachelors degree in clinical/medical laboratory science (CLS/MLS), medical technology (MT), chemistry, a human biological science, or within histopathology or non:testing laboratories, a bachelors degree with laboratory certification if applicable. Two years of relevant laboratory experience required. An HEW certification may be substituted for the specified degree.

Additional Qualifications: Clinical laboratory experience is preferred as well as understanding of basic clinical laboratory quality management concepts and regulatory/accreditation requirements. Highly organized, efficient, and able to work independently exercising strong decision:making skills. Certification in a laboratory science such as ASCP is preferred.

In addition:
:Working knowledge of quality systems and regulatory requirements (21 CRF Part 1271 both 351 and 361 products).
:Experience with regulatory affairs a plus, specifically in cell therapy (FDA, FACT, AABB, cGMP).
:Excellent interpersonal, verbal and written communication skills are essential in this collaborative work environment.
:Exceptional mathematical skill and analytical skill.
:Decisive and action oriented with proven problem solving capabilities, detail oriented, accurate record keeping, ability to work in a fast paced, changing environment required.
:An independent, flexible, high:energy team player with a demonstrated record of achievements in quality assurance and quality control in biologics.
:Computer software skills including PC based spreadsheet/database software.
:The ideal candidate is well versed in various analytical techniques such as FACS, ELISAs, PCR and other applicable methods to the testing of biopharmaceuticals.
:Experience with equipment and utility IQ/OQ/PQ.
:Ability to communicate and work independently with scientific/technical personnel.
:Self:motivated and willing to accept temporary responsibilities outside of initial job description.

Benefit Eligible: Yes
Exemption Status: Exempt
Compensation Detail: Education, experience, and tenure may be considered along with internal equity when job offers are extended. The minimum pay rate is 2,180 per pay period.
Hours/Pay Period: 80
Schedule Details: M:F 11:00 am. to 7:30 pm.
Occasional flexing as required to accommodate workload.
Weekend Schedule: Occasional to meet patient workload.

Recruiter: Lauren Brandt

Why Mayo Clinic? Mayo Clinic provides the highest quality patient care by placing the needs of the patient first. Youll discover a culture of teamwork, professionalism and mutual respect - and most importantly, a life:changing career. We invite you to join our diverse team as we provide health, hope and healing to people from all walks of life.

Site Description: Mayo Clinic is located in the heart of downtown Rochester, Minnesota, a vibrant, friendly city that provides a highly livable environment for more than 34,000 Mayo staff and students. The city is consistently ranked among the best places to live in the United States because of its affordable cost of living, healthy lifestyle, excellent school systems and exceptionally high quality of life.

Mayo Clinic is an equal opportunity educator and employer (including veterans and persons with disabilities).

Job Posting Category: Clinical Labs
Job Posting Number: 59350BR

Salary: Competitive

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