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Specialist Quality Assurance
1571 Van Buren Road Easton, PA 18045 US
Job Description
Responsibilities:
• Ensure operations align with applicable regulations and internal requirements relating to Good Manufacturing Practices, Good Distribution Practices, Good Documentation Practices, and Safety
• Collaborate with the LSP to ensure adherence to service levels, identifying performance improvement opportunities in alignment with the Operations READ framework (reliability, efficiency, agility, differentiation)
• Implement business continuity for services and processes
• Partner with key internal customer groups and/or outside vendors to ensure successful operations
• Participate / Conduct quarterly Business / Quality reviews and address service failures with the LSP
• Ensure metric targets are achieved and establish standardized mechanisms to measure progress against targets
• Understand and incorporate risk management strategy into overall supply chain strategy
• Ensure compliance with required training for staff supporting company business
• Provide leadership, guidance, mentorship, and training to staff and partner groups
• Perform receipt, storage, and distribution documentation review to ensure alignment with procedures, current Good Manufacturing Practices (cGMP), Good Distribution Practices (GDP) and other applicable regulations
• Perform cGMP process, procedure, document and record review, and approval, including but not limited to deviations, CAPAs, change controls, risk assessment, and validation records
• Perform incoming raw material inspection, environmental monitoring, and documentation review
• Provide leadership updates regarding the health and initiatives relating to the QMS at site management reviews
Preferred Qualifications:
• Ability to liaise/communicate effectively and easily with cross-functional teams and different cultures (excellent written and verbal communication skills)
• Self-leadership and motivation
• Strategic mindset
• Serves as a role model for company Values
• Understanding of industry requirements (GMP, GDP, Import/Export) Scientific degree in Life Sciences or Physical Sciences or Applied Engineering or Manufacturing Technologies
• Previous QA oversight of distribution, warehousing, incoming QA, manufacturing, validation, and facility and engineering activities
• Experience in deviation, change controls, and CAPAs processes system knowledge
• Ability to evaluate compliance issues and interact with regulatory inspectors
• Experience and training in Veeva, SM LIMS, ERP
• Experience in managing multiple, competing priorities in a fast-paced environment
• Experience leading and/or managing teams
• Direct drug substance and/or drug product experience
• Ability to solve complex problems and make scientific risk-based decisions
• Experience representing company while interacting with representatives of regulatory agencies
• Demonstrated proficiency using Excel, Word, and PowerPoint
Pay Rate Range: 30-38/hr depending on experience
The staffing industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly and never provide banking information during the application process. Candidate safety is a top priority at Planet Pharma.
Planet Pharma is an equal opportunity employer. It is our practice not to discriminate against any employee or applicant based on any criteria, condition or basis protected by laws or regulations in the locations where we do business. All qualified applicants are encouraged to apply. We celebrate diversity and are committed to providing an environment of mutual respect. We believe that diversity, equity and inclusion enable us to better meet our mission and values while serving our clients across the globe. If you have a disability or handicap and would like us to accommodate you in any reasonable way, please inform your recruiter, or contact us, so that we can discuss the appropriate alternatives available.
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