Analytical Validation Specialist
An Analytical Validation Specialist is needed for a Swiss multinational manufacturing company for the pharmaceutical, biotechnology and nutrition sectors, in the Portsmouth, NH area. The Analytical Validation Specialist leads validation activities for analytical systems, ensuring compliance, process improvements, and cross-functional collaboration to support quality and operational excellence.
location: Portsmouth, New Hampshirejob type: Contract
salary: $51.33 - 77.00 per hour
work hours: 8am to 5pm
education: Bachelors
responsibilities:
- Lead validation activities for software updates, new system introduction, and decommissioning of analytical systems.
- Collaborate with Manufacturing, Operations Technology, Computer System Validation, Engineering, and Quality Assurance teams.
- Ensure compliance with regulatory guidelines and contribute to quality, on-time delivery, and right-first-time performance.
- Provide Subject Matter Expert (SME) support to Quality Control, Manufacturing, and other departments for analytical equipment.
- Develop and execute validation plans for analytical equipment changes and process improvements.
- Perform Installation Qualification (IQ), Operational Qualification (OQ), and draft Performance Qualification (PQ) as required.
- Own and manage TrackWise (TW) records, including Change Controls (CC), Corrective and Preventive Actions (CAPA), and Deviations.
Skills:
- Advanced knowledge of Quality Control and Manufacturing Operations.
- Experience with Quality Systems, including deviations, change controls, CAPAs, and compliance tracking (e.g., TrackWise).
- Expertise in process, equipment, cleaning, and computer system validations.
- Project management experience, particularly in managing medium-to-large projects within set timeframes.
- strong planning, organizing, and control competencies.
- strong written and verbal communication skills.
- Proficiency in MS Project, Word, Excel, and PowerPoint.
Education and Experience:
- Bachelor's degree in a science-related discipline or relevant industry experience.
- 5-10 years of experience in analytical validation, quality control, or related fields.
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qualifications:
- Experience level: Experienced
- Education: Bachelors
- Validation
- Compliance
- Technical Writing
- Regulatory
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 health, an incentive and recognition program, and 401K contribution (all benefits are based on eligibility).
This posting is open for thirty (30) days.