Specialist Quality Assurance
The QA will provide quality support and oversight of the commissioning & qualification and process qualification of the facility, utilities, computer systems and equipment. They will collaborate cross-functionally to ensure project timelines and milestones are met. location: Holly Springs, North Carolina
job type: Contract
salary: $32.00 - 37.96 per hour
work hours: 9 to 5
education: High School responsibilities:
- Support the Quality oversight associated with Commissioning & Qualification (C&Q) and validation activities for site. These activities will involve facilities/utilities, equipment/systems, computerized systems, process and validation maintenance.
- Perform quality review of documents to support facility commissioning and qualification, according to project timelines.
- Commissioning / Qualification Protocols
- Performance Qualification Protocols (PQ)
- Review and Approval of protocol discrepancies
- Review of Final Reports and Summary Documents
- Provide quality support during execution of commissioning and qualification testing, reviewing and approving changes and discrepancies, as required.
- Ensure that all activities & related documentation for facilities, equipment, materials, and processes comply with applicable regulations and Company requirements relating to Good Manufacturing Practices, Good Documentation Practices, Safety, and Controls.
- Ensure documents comply with Company's procedures, regulatory expectations (e.g., FDA, EMA), and Good Documentation Practices (GDP).
- Provide timely feedback and collaborate with authors and engineers to address document gaps or discrepancies.
- Participate in meetings related to document planning, execution, and issue resolution.
- Escalate any compliance concerns or critical gaps to QA management.
- In line with business requirements, these responsibilities may expand or otherwise include additional areas of responsibility which are not described in this specification but are associated with the role.
qualifications:
- Doctorate degree OR Master degree and 3 years of experience OR Bachelor degree and 5 years of experience OR Associate degree and 10 years of experience OR High school diploma / GED and 12 years of experience
- Understanding of regulatory requirements, trends, and industry standards.
- Experience/knowledge in commissioning/qualification/validation, including computer-systems validation.
- Excellent written and verbal communication skills.
- Ability to work in a team matrix environment and build relationships with partners.
- Great attention to detail and high degree of accuracy in task execution and GMP documentation.
- Ability to complete tasks autonomously, providing updates to senior management, identifying potential issues, and following assignments through to completion.
- Proven capability and experience applying GMP requirements in an operational and Quality Control setting.
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 [email protected].
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.
Recommended Jobs
Bilingual Patient Service Representative - PSR
SUMMARY: Patients Service Representatives (PSRs) coordinate across patient care continuum by being the first and most frequent contact with patients, families, providers, and office staff. PSRs assis…
Field Operations Intern (Summer 2026)
Employment Type: Intern Division: Field Operations Department: Field Operations The Field Operations Intern supports Superintendents and Project Managers by assisting with safety progra…
Category Manager, Strategic Sourcing
WHAT MAKES US EPIC? At the core of Epic’s success are talented, passionate people. Epic prides itself on creating a collaborative, welcoming, and creative environment. Whether it’s building award-wi…
Clinical Scientist - Clinical Surveillance & Training (Clinical Psychologist/Neuropsychologist)
Clinical Scientist - Clinical Surveillance & Training (Clinical Psychologist/Neuropsychologist) Syneos Health® is a leading fully integrated biopharmaceutical solutions organization built to acceler…
Banquet Server
Banquet Server REPORTS TO: Dining Room Manager, Bar Supervisor, and Waitstaff Captains. JOB SUMMARY: Sets banquet areas, and serves beverages and food to club members and guests according t…
Python AI/ML Developer
Kforce's client is hiring multiple Python Developers in Wilmington (DE) & Columbus (OH). These opportunities are for full-time employment, so relocation candidates are welcome to apply. Job Responsib…
Construction Tradesman (Mobile)
**This role will assist numerous facilities in the South Charlotte area to include: retail, Single family rentals, residential properties, industrial. **Experience in moderate construction work requ…
Land Administrator
The Land Administrator is responsible for obtaining, reviewing and documenting information related to new communities and lots within the communities. The Land Administrator will collaborate with each…