Advance your career with a premier global biopharmaceuticals leader in historic Portsmouth, NH! We are seeking a detail-oriented QC Specialist III-Documentation to join our Quality Control team on a 100% onsite first-shift schedule. In this pivotal role, you will manage QC chemical raw material specifications and data entry within LIMS and Document Management Systems (DMS) to support high-impact manufacturing operations.
location: Portsmouth, New Hampshire
job type: Contract
salary: $50.00 - 53.96 per hour
work hours: 9 to 5
education: Associate
responsibilities:
- Manage, update, and own chemical raw material specifications, SOPs, and work instructions via compliance records or change requests.
- Create and update LIMS templates and master data for new and existing raw material specifications.
- Collaborate cross-functionally with Raw Material Scientists and Coordinators to ensure accurate, functional testing specifications.
- Apply strict Data Integrity principles across all documentation, change management, and LIMS entries in compliance with cGMP standards.
- Communicate effectively with stakeholders to ensure specification updates are accurately executed.
qualifications:
Required:
- Associate degree in a science-related field.
- Minimum of 2 years of editing, document control, or regulated biotech/pharma industry experience.
- Demonstrated experience using Document Management Systems (DMS) and managing document change processes.
- Strong technical writing skills and advanced proficiency in MS Office (Word and Excel).
- Working knowledge of cGMP regulations and compendia standards (e.g., USP, EP).
- Direct experience creating and managing templates within a LIMS platform.
skills: MS-EXCEL, Laboratory Information Management Systems (LIMS), Good Documentation Practices (GDP)
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.
