Specialist Quality Assurance

Job Description

Job Description

job summary:

As a trusted staffing and recruitment partner, we are committed to connecting you with the perfect opportunity at a global leader in biotechnology. Leveraging our extensive network, we provide access to top-tier roles that allow you to grow and make a meaningful impact in the healthcare and life sciences industries. This company is dedicated to discovering and developing innovative therapies that address serious diseases, with a focus on oncology, cardiology, and bone health. With a strong legacy of scientific excellence and a mission to improve patient outcomes worldwide, they offer a dynamic environment where your contributions will drive real change. If you're seeking a rewarding career that makes a difference, let us help you take the next step!

location: Easton, Pennsylvania
job type: Contract
salary: $35.00 – 43.12 per hour
work hours: 9 to 5
education: Bachelors

responsibilities:

• Ensure operations align with applicable regulations and Company 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 Company 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 Company 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

qualifications:

Required:

• Bachelor's degree with 5+ years of related experience
• Pharmaceutical or other life sciences industry experience

Preferred:

• Strong preference for candidates with:
  • Raw material QA experience
  • GMP-regulated industry background
  • Pharmaceutical or biotech experience is ideal, but cross-industry candidates may be considered if GMP and raw material inspection experience is clear.
  
  

#LI-HK1

skills: SOP, Quality Assurance, CAPA, GMP (Good Manufacturing Practice)

Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.

At Randstad, we welcome people of all abilities and want to ensure that our hiring and interview process meets the needs of all applicants. If you require a reasonable accommodation to make your application or interview experience a great one, please contact HRsupport@randstadusa.com.

Pay offered to a successful candidate will be based on several factors including the candidate's education, work experience, work location, specific job duties, certifications, etc. In addition, Randstad offers a comprehensive benefits package, including: medical, prescription, dental, vision, AD&D, and life insurance offerings, short-term disability, and a 401K plan (all benefits are based on eligibility).

This posting is open for thirty (30) days.

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