Planning, implementation and surveillance of entire QMS; ensure compliance with ISO, FDA, EU and USDA regulations (6 facilities across state of PA).
Responsibilities include but are not limited to:
Planning, implementation and surveillance of entire QMS; ensure compliance with ISO, FDA, EU and USDA regulations (6 facilities across state of PA)
Establish and monitor performance of company Quality Policy and Objectives
Assist in preparation, hosting, execution, and responses for client, regulatory and internal audits
Maintain and evaluate effectiveness of company-wide training program
Performs staff and all company trainings
Assist in preparation, Coordination, Reporting and Follow up on all Management Review meetings
Document and review of Quality Technical, Supply and Distribution Agreements
Assist with all investigations, corrections and CAPAs for customer complaints, NCRs, and audit findings.
Supplier Management program, involving ranking, auditing and surveillance of all suppliers
Review of all controlled documents, customer specifications, change controls and validations, including software validation.
Production and Process Controls which include, material receiving, calibration and equipment maintenance, environmental monitoring and pest management, identification and traceability, record rview, labeling, packaging and shipping activities
Assists QA Specialists in release of finished goods, Material Receiving and Quarantine and disposition of nonconforming materials
Assist QA Director with client requested documentation such as supplier questionnaires and health certificates.
In charge of all facility record retention and archival program
•BS Degree in scientific discipline preferred
•Minimum 5 years of experience in quality assurance management role
•Experience with ISO 9001, ISO 13485 and/or 21CFR820
•Experience with client and regulatory audits/inspections
•Experience with cGMP (21CFR820) quality systems and manufacturing operations, experience with 21CFR211 and/or 21CFR58 is a plus
•Experience with USDA Requirements for shipping animal blood products is preferred
•Well-organized and detailed oriented professional, with strong written communication skills
•Good computer skills with working knowledge of MS office such as Word and Excel
•MS Access knowledge would be a plus
•Must be self-motivated with ability to handle, organize and prioritize multiple tasks and meet deadlines
• Bachelors/Associates degree in science or similar field, or equivalent experience
Lampire Biological Laboratories offers a competitive salary, medical, dental, life, disability insurances, 401k with matching contribution and profit sharing.
Lampire Biological Labs, Inc. is an equal opportunity employer. All qualified applicants receive consideration for employment without regard to race, color, religion, sex, or national origin.