Quality Assurance Specialist - Inspection

Specialist Quality Assurance - Inspection

Location: Easton, PA

Onsite Flexibility: Onsite

Contract Details

• Position Type: Contract
• Contract Duration: 18 months
• Work Authorization: Applicants must be authorized to work for ANY employer in the U.S. We are unable to sponsor or take over sponsorship of an employment Visa at this time.

Job Summary

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). Strong attention to detail, comfort in a warehouse environment, and GMP compliance experience are essential.

Key Responsibilities

• Ensure that all operations comply with relevant regulations and requirements, including Safety, Good Manufacturing Practices (GMP), Good Distribution Practices (GDP), and Good Documentation Practices
• Conduct sampling and inspection of incoming raw materials, assess documentation, and determine disposition
• Compile and review documentation associated with receipt, storage, incoming inspection, and distribution
• Perform routine Quality Assurance assessments and provide direct operational oversight
• Provide expert advice on quality matters to operational teams and cross-functional groups
• Ensure staff complete necessary training related to business operations
• Approve GMP processes, procedures, documents, and records, addressing deviations, CAPAs, change controls, risk assessments, and validation records as required
• Achieve established metric targets and develop standardized approaches for tracking progress
• Collaborate with Logistic Service Providers (LSPs) to maintain service levels and identify areas for performance enhancement
• Represent the Quality Unit during audits and inspections, directly interacting with regulatory agencies
• Support internal and external audits and inspections as a member of the audit/inspection team
• Perform additional duties as assigned by management

Required Skills

• Warehousing
• Raw material incoming inspection and sampling
• Raw material disposition

Preferred Skills

• Proven ability to communicate effectively with cross-functional teams and diverse cultures, both verbally and in writing
• Academic background in Life Sciences, Physical Sciences, Applied Engineering, or Manufacturing Technologies
• Prior experience overseeing QA in distribution, warehousing, manufacturing, validation, and engineering functions
• Expertise in managing deviations, change controls, and CAPAs
• Proficiency in Veeva, SM LIMS, and ERP systems
• Knowledge of industry standards (GMP, GDP, Import/Export)
• Demonstrated self-leadership and motivation
• Strong strategic thinking skills
• Ability to evaluate compliance issues and engage with regulatory inspectors
• Experience managing multiple priorities within a dynamic environment
• Direct experience with drug substances and/or drug products
• Advanced problem-solving abilities and capacity for scientific, risk-based decision-making
• Track record of representing an organization during regulatory interactions
• High proficiency in Microsoft Excel, Word, and PowerPoint

Education Requirements

• Doctorate degree OR Master's degree and 3 years of experience OR Bachelor's degree and 5 years of experience OR Associate degree and 10 years of experience OR High school diploma / GED and 12 years of experience
• Bachelor's degree strongly preferred

Required Experience

• Minimum 5 years of QA experience specifically involving raw materials in a GMP-regulated environment such as pharmaceutical, biotech, or other life sciences industries

Work Environment / Physical Requirements

• Role is physically active; candidates must be comfortable in a warehouse environment
• Must pass an eye exam prior to placement
• Lifting of materials approximately 40 lbs required
• Consistent gowning required (jumpsuit, scrubs, goggles)
• Candidate must report onsite daily at Langham Logistics, a third-party GMP-compliant warehouse in Easton, Pennsylvania
• Candidates must be local or self-relocate; no exceptions

Important Notes

• This role is classified as onsite; candidates seeking remote-only work should not apply
• Candidates without a QA/GMP/raw materials background will not be considered

Benefits

• Medical, Vision, and Dental Insurance Plans
• 401k Retirement Fund

About GTT

GTT is a minority-owned staffing firm and a subsidiary of Chenega Corporation, a Native American-owned company in Alaska. We highly value diverse and inclusive workplaces and support Fortune 500 organizations across banking, financial services, technology, life sciences, biotech, utilities, and retail sectors throughout the U.S. and Canada.

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