QC Specialist II

job summary:
The QC Specialist II will join the Quality Control department in Portsmouth. This role is pivotal in supporting production through technical transfer activities, in-process testing, and final product stability studies. The ideal candidate will bridge the gap between routine lab work and high-level quality documentation, ensuring data integrity and compliance within a fast-paced GMP environment.

location: Portsmouth, New Hampshire
job type: Contract
salary: $31 - 33 per hour
work hours: 9 to 5
education: Associate

responsibilities:

• Technical Transfer & Validation: Support the completion of tech transfer activities, method qualifications, and new instrument integration.
• Analytical Testing: Execute test samples for In-Process, Lot Release, and Stability studies.
• Quality Documentation: Author and review critical quality records, including Deviations, CAPAs, Change Controls, and Test Methods.
• Data Integrity: Apply rigorous Data Integrity principles to all laboratory computer systems and manual records.
• Subject Matter Expertise: Act as a SME for specific software systems; troubleshoot software errors and perform root-cause analysis.
• Collaboration: Coordinate with cross-functional teams to interpret priorities and ensure timely project completion.

 
qualifications:

• Education: Associate's or Bachelor's Degree in Microbiology, Biochemistry, or a related Scientific field
• Experience: 2-4 years of GMP experience within the pharmaceutical or biotech industry
• Technical Skills: Proficiency with Empower, SoftmaxPro, or SoloVPE is highly preferred
• Software Validation: Experience writing GMP procedures, validation documents, and executing test scripts
• Quality Systems: Familiarity with LIMS and TrackWise is a plus
• Communication: Strong ability to interpret complex data and present findings to the broader team

 
skills: Microbiology, Laboratory Information Management Systems (LIMS), Good Manufacturing Practices (GMP)


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.