QC Systems & Validation Analyst III (SoftMax Pro / Empower)

job summary:
Join a top-tier global pharma leader on-site in Portsmouth, NH, as a QC Analyst 3. In this 8-month contract role, you will play a key part in technical transfer activities, method/software validations, and ensuring overall quality control compliance in a fast-paced environment.

location: Portsmouth, New Hampshire
job type: Contract
salary: $62.00 - 64.75 per hour
work hours: 9 to 5
education: Bachelors

responsibilities:

• Perform technical transfer activities and contribute to quality control operations within a GMP pharmaceutical setting.
• Execute method and software validations, write GMP procedures, compile validation documentation, and execute test scripts.
• Serve as a Subject Matter Expert (SME) for key laboratory computer systems and software applications.
• Perform technical, root-cause analysis for software errors while maintaining strict adherence to Data Integrity principles.
• Collaborate with cross-functional teams to identify priorities and ensure on-time, compliant deliverables.

 
qualifications:
Required:

• Bachelor's degree in a science-related field.
• Hands-on GMP experience within the pharmaceutical industry.
• Hands-on experience with SoftmaxPro, Empower, or SoloVPE software.
• Proven experience writing GMP procedures, validation documents, and executing test scripts.
• Strong knowledge of Data Integrity principles and experience using laboratory computer systems.
• Excellent written and verbal communication skills with strong analytical ability.

Preferred:

• Prior experience with GMP Quality Systems such as TrackWise or LIMS.

 
skills: Laboratory Information Management Systems (LIMS), Good Manufacturing Practices (GMP), Quality Assurance (QA), Quality Control (QC)




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 us.fitly.work.




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.