Quality Assurance Specialist

Aditi Consulting; Easton (Northampton County); On-site; USD 60,000 - 80,000; Full time

Job summary

A leading company in the life sciences field is searching for a Quality Assurance Specialist with significant QA experience in a GMP environment. The role demands physical activity, attention to detail, and the ability to work onsite daily while ensuring compliance with industry standards. This position offers competitive hourly pay and various benefits, including paid time off and retirement plan options. Ideal candidates will possess a strong background in QA processes and leadership skills.

Benefits

Medical, dental, and vision benefits

401(k) plan participation

10 paid days off

Commuter benefits

Life and disability insurance

Qualifications

• 5 years of QA experience in GMP-regulated environments.
• Strong communication skills and ability to collaborate effectively.
• Experience in deviation, change controls, and CAPAs.

Responsibilities

• Ensure compliance with Good Manufacturing Practices and safety regulations.
• Collaborate with internal teams and vendors to achieve objectives.
• Conduct reviews of documentation to ensure adherence to regulations.

Skills

Attention to detail

Quality Assurance

GMP compliance

Education

Bachelor's degree in Life Sciences

Master's or Ph.D. (preferred but not required)

Job description

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Payrate: $ 25.50- $37.50/ hr.

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). While officially remote (per internal classification), the worker must be onsite daily. 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 Company’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 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 Company while interacting with representatives of regulatory agencies
• Demonstrated proficiency using Excel, Word, and PowerPoint

Top 3 Must Have Skill Sets:

• 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
• Direct drug substance and/or drug product experience

Pay Transparency: The typical base pay for this role across the U.S. is: $25.50 - $37.50 / hr. Final offer amounts, within the base pay set forth above, are determined by factors including your relevant skills, education and experience and the benefits package you select. Fulltime employees are eligible to select from different benefits packages. Packages may include medical, dental, and vision benefits, 10 paid days off, 401(k) plan participation, commuter benefits and life and disability insurance.

For information about our collection, use, and disclosure of applicant's personal information as well as applicants' rights over their personal information, please see our Privacy Policy (https://www.aditiconsulting.com/privacypolicy).

Aditi Consulting LLC uses AI technology to engage candidates during the sourcing process. AI technology is used to gather data only and does not replace human based decision making in employment decisions. By applying to this position, you agree to Aditi’s use of AI technology including calls from an AI Voice Recruiter.

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Seniority level

• Seniority level

  Entry level

Employment type

• Employment type

  Contract

Job function

• Job function

  Quality Assurance

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