QA QMS / Compliance Specialist (SOP Harmonization)

job summary:
Looking to make a significant impact on global quality operations? A Top-Tier Global Pharma Leader in Portsmouth, NH is seeking a detail-oriented QA Compliance Specialist 2 for a 6-month contract. This pivotal role will focus on driving site-level compliance by performing gap analyses between local and global SOPs, managing CAPA developments, and supporting key Quality Management System (QMS) initiatives.

location: Portsmouth, New Hampshire
job type: Contract
salary: $83.00 - 85.02 per hour
work hours: 9 to 5
education: Bachelors

responsibilities:

• Lead structured gap assessments comparing local QMS procedures against corporate standards and global quality requirements.
• Coordinate remediation activities and updates for local SOPs, work instructions, and controlled documents.
• Partner with process owners and SMEs across Engineering, Manufacturing, and Quality to implement compliant solutions.
• Support Change Control, CAPA development, Deviations, and Quality Risk Management activities.
• Monitor compliance metrics, track execution against defined timelines, and prepare visual KPI reporting for management.

 
qualifications:
Required:

• Bachelor's degree in a scientific field or equivalent experience.
• 3+ years in a cGMP environment with dedicated experience in Quality Assurance.
• Strong knowledge of cGMP regulations, QMS standards, and gap analysis methodology.
• Demonstrated project management skills, including meeting facilitation and stakeholder collaboration.
• Ability to handle tight timelines and manage multiple compliance priorities effectively.

Preferred:

• Biotechnology manufacturing background.
• Hands-on experience with TrackWise, SAP, and electronic document management systems (eDMS).

#LI-MH1

skills: SOP Development, Good Manufacturing Practices (GMP), Corrective and Preventive Actions (CAPA), 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 View email address on 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.