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Quality Manager Trainee BioLife/Shire

Quality Manager Trainee - $48,000 Salary and Program Completion Bonus!

About Us
Shire is the leading global biotechnology company focused on serving people with rare diseases and other highly specialized conditions. We have best-in-class products available in more than 100 countries across core therapeutic areas including Hematology, Immunology, Neuroscience, Lysosomal Storage Disorders, Gastrointestinal / Internal Medicine / Endocrine and Hereditary Angioedema; a growing franchise in Oncology; and an emerging, innovative pipeline in Ophthamolics. Our employees come to work every day with a shared mission: to develop and deliver breakthrough therapies for the hundreds of millions of people in the world affected by rare diseases and other high-need conditions, and who lack effective therapies to live their lives to the fullest.
A subsidiary of Shire, BioLife is an industry leader in operating high quality plasmapheresis centers throughout the United States. BioLife currently has over 90 Plasma Center locations across the United States, and we are growing!
Our Mission
To provide the highest-quality plasma to meet the expectations of our customers, ensuring the availability of life-saving therapies for patients.
Our Vision
To be the leading plasma supply company in the world by continuously improving, to ensure:
  • Every employee is valued and a fully engaged member of our team
  • Every donor is recognized for his or her contribution and given exceptional service
  • Every process is innovative and efficient
  • Every customer is delighted with our performance
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  • About the Quality Manager Trainee Role
  • Shire is looking for self-motivated individuals to enter into our thorough Quality Management Trainee Program, and advance into a Quality Representative position at one of our US BioLife Plasma Center locations across a wide network. As a Quality Manager Trainee you will have the opportunity to travel to multiple dynamic and unique work environments, through our comprehensive travel package.
  • Qualifications for this role: Bachelor’s Degree or an equivalent amount of leadership experience (approx. 1 or more years)
  • Experience working with SOPs, GDP, GMP, CLIA, FDA or within another highly regulated industry preferred.
  • Primary Responsibilities of the Quality Manager Trainee role include:
  • Regulatory Compliance including: stays current with federal, state, local and company-specific rules, regulations, and practices. Ensuring center compliance with all federal, state, local and company-specific regulations related to quality of product, employee and donor safety for a plasma center producing approximately 60,000 liters or more per year. Also, ensuring that SOP’s are current and that staff perform routine tasks according to SOP through direct observation.
  • Plasma Collection Center Quality Assurance Oversight
  • Reviews operational records to ensure they are complete, accurate and compliant with cGMP requirements.
  • Tracks deviations and trending in operating procedures and policies through established mechanisms. Reports errors, deficiencies, discrepancies and observations to center management and the Regional Quality Manager. May stop operations or shipments when donor or product safety is or may be compromised.
  • Identifies potential SOP revisions as needed to support continuous improvement.
  • Works in collaboration with center manager and management team to prepare for and host (if needed) internal auditors and external inspectors. Assists center management teams to ensure timely closure of audit observations.
  • Tracks responses to and evaluates effectiveness of corrective actions for errors.
  • 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, and employee training program.
  • Coordinates management review meetings and participates in center staff meetings.
  • Works collaboratively with staff, peers, and management to achieve business goals. Communicates continuously at all levels of the organization and resolves conflicts proactively.
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The Quality Manager Trainee development program will be for a period of up to 12 months. After completion of the development program, Quality Manager Trainees will have an additional 6 months to establish a management position.
Other Important Requirements:
  • During the Quality Management Trainee Program, trainees must either live near a BioLife Plasma Services location or relocate to either Appleton, WI or Covington, GA.
  • Must maintain a valid driver’s license for the entire duration of the program
  • Ability to travel up to 75%-85% of the time for duration of training program, and relocation upon completion of program.
  • Office/Production environment. May require weekend and extended work periods
  • Attend staff meetings and other team meetings as needed
  • Requires frequent leaning, bending, stooping, crouching, and reaching above the shoulders and below the knee, and occasional lifting up to 50 pounds
  • Potential exposure to blood borne pathogens
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  • Joining the Shire team also means being offered amazing benefits!
Our comprehensive benefits package includes:
  • Major Medical, Dental and Vision Insurance & Prescription Coverage for Eligible Employees
  • Generous Vacation and Company Paid Holidays
  • Vacation minimum of 15 days and 10 paid holidays
  • Comprehensive Tuition Reimbursement Program
  • Retirement Savings Program
  •  Generous employer contribution and Matching Program
  • Short and Long Term Disability Insurance
  • Life and AD&D Insurance