Job Description

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

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