Job Title: Specialist Quality Control
Location: Easton PA
Duration: 18 Months with Possible extension
Terms: Contract W2
Description:
ONSITE AT: Easton, Pennsylvania reporting daily. The candidate will physically work on-site at Langham Logistics, a third-party GMP-compliant warehouse in Pennsylvania.
Expected hours: 8:00 AM to 5:00 PM, Monday–Friday.
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. This role is physically active and requires passing an eye exam, lifting materials (~40 lbs), and consistent gowning (jumpsuit, scrubs, goggles). While officially remote (per internal classification), the worker must be onsite daily. Candidates must be local or self-relocate by 8/4 no exceptions. Strong attention to detail, comfort in a warehouse environment, and GMP compliance experience are essential. Avoid candidates seeking remote-only work or lacking QA/GMP/raw material background.
Responsibilities:
• Ensure operations align with applicable regulations and 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 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 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 Description Job Description Salary: 17 Job Title : PCA Location : Varies Locations Job Type : PRN Reports To : Client Coordinator Job Description : We are seeking a compassionate and dedicated PRN PCA dto provide non-medical support to individuals...
...start-up is looking for an ambitious and target driven individual in the San Diego County area to join their team as a Clinical Data Manager. In this position, you will play a crucial role in the collection, cleaning, and management of data generated during clinical...
...landscape products, ready-mixed concrete, asphalt, paving and construction services. We succeed as a team by embracing integrity, mutual... ...leaving the pit. Travel from interstate highway to rural dirt roads from various locations. Supervisory Responsibilities...
...accurate service Contribute to our exceptional track record for safety Have other opportunities to learn and expand your knowledge.... ...love helping others and will support the needs of our guests and associates. Good judgement and a commitment to safety. Ability to work and...
...Position Summary: The Manager of Individual Giving and Donor Communications plays a key role in advancing the fundraising goals of the organization. This individual will manage and grow the individual giving and digital fundraising programs, contribute to major gift...