Job Description
Job Title: Specialist Quality Assurance
Duration: 18 Months
Location: Easton, PA 18045 (Langham Logistics Warehouse – third-party GMP site)
Expected hours : 8:00 AM to 5:00 PM, Monday–Friday.
The candidate will physically work on-site at Langham Logistics, a third-party GMP-compliant warehouse in Pennsylvania.
Description:
Responsibilities:
- Ensure operations align with applicable regulations and client's 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 Client 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 client's 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:
- The ideal candidate will have 5+ years of QA experience ****specifically involving raw materials*****in a GMP-regulated environment such as pharmaceutical, biotech, or other life sciences industries. A bachelor’s degree is strongly preferred; master’s candidates may be considered, but Ph.D.-level talent may be too senior for the scope.
- 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 client's 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 while interacting with representatives of regulatory agencies.
- Demonstrated proficiency using Excel, Word, and PowerPoint.
Job Tags
Monday to Friday,