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: $30.00 - 36.09 per hour
work hours: 9 to 5
education: Bachelors
responsibilities:
- Ensure that all operations comply with relevant regulations and Company 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 Company 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
qualifications:
- 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)
- Commitment to exemplifying Companys core values
- 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
skills: Laboratory Information Management Systems (LIMS), Good Laboratory Practices (GLP), Veeva Vault, Good Manufacturing Practices (GMP), Quality Assurance (QA)
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.
Any consideration of a background check would be an individualized assessment based on the applicant or employee's specific record and the duties and requirements of the specific job.
