Shire Manager Trainee - Quality (Covington, GA) in Remote, Georgia
Regulatory Compliance: (15%)
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.
Ensures that SOP’s are current and that staff perform routine tasks according to SOP through direct observation.
Plasma Collection Center Quality Assurance Oversight: (80%)
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. (5%)
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.
EEO is the Law - https://www.dol.gov/ofccp/regs/compliance/posters/pdf/eeopost.pdf
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.