Shire Manager Trainee - Quality in United States
Quality Manager Trainee - $48,000 Salary and Program Completion Bonus!
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!
To provide the highest-quality plasma to meet the expectations of our customers, ensuring the availability of life-saving therapies for patients.
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 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.
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 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
Notice to Employment / Recruitment Agents:
Employment / Recruitment agents may only submit candidates for vacancies only if they have written authorization to do so from Shire’s Talent Acquisition department. Any agency candidate submission may only be submitted to positions opened to the agency through the specific Agency Portal. Shire will only pay a fee for candidates submitted or presented where there is a fully executed contract in place between the Employment / Recruitment agents and Shire and only if the candidate is submitted via the Agency Portal. Candidates submitted or presented by Employment / Recruitment Agents without a fully executed contract or submitted through this site shall not be deemed to form part of any Engagement for which the Agency may claim remuneration.
Equal Employment Opportunity
Shire is an Equal Opportunity Employer committed to a diverse workforce. Shire will not discriminate against any worker or job applicant on the basis of race, color, religion, gender, national origin, ancestry, age, sexual orientation, marital or civil partnership status, pregnancy, gender reassignment, non-job related mental or physical disability, genetic information, veteran status, military service, application for military service, or membership in any other category protected under law.
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EEO is the Law – Supplement - https://www.dol.gov/ofccp/regs/compliance/posters/pdf/OFCCPEEOSupplementFinalJRFQA508c.pdf
Pay Transparency Policy - https://www.dol.gov/ofccp/pdf/pay-transp_formattedESQA508c.pdf
Shire is committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please call 484-595-8400 and let us know the nature of your request and your contact information.
Shire is the leading global biotechnology company focused on serving people with rare diseases and other highly specialized conditions. We strive to develop best-in-class products, many of which are available in more than 100 countries, across core therapeutic areas including Hematology, Immunology, Neuroscience, Ophthalmics, Lysosomal Storage Disorders, Gastrointestinal/Internal Medicine/Endocrine and Hereditary Angioedema; and a growing franchise in Oncology.
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.