QC Specialist II (Quality Control Technical Transfer Analyst)
Location: Portsmouth, NH
Work Type: 100% On-site
Duration: Contract (Apr 6, 2026 – Apr 2, 2027)
Pay Rate: $33/hour
Job Overview
We are seeking a QC Specialist II / Quality Control Technical Transfer Analyst to support Quality Control laboratory operations in a GMP pharmaceutical manufacturing environment. The role will focus on technical transfer activities, QC testing, method validations, and stability studies while ensuring compliance with data integrity and regulatory standards.
This individual will collaborate with cross-functional teams to support in-process testing, lot release testing, investigations, and method transfers.
Key Responsibilities
- Support technical transfer activities within the Quality Control department.
- Perform QC laboratory testing for:
- In-process samples
- Lot release testing
- Stability studies
- Execute testing for investigations, method transfers, and validations.
- Review assay data and analytical results.
- Write and manage quality documentation, including:
- Deviations
- CAPAs
- Change Controls
- Test Methods
- Support method transfer, instrument qualification, and new technology implementation.
- Perform root cause analysis for technical or software-related issues.
- Ensure compliance with GMP regulations and Data Integrity (DI) principles.
- Act as Subject Matter Expert (SME) for at least one laboratory software system.
- Train junior staff and provide guidance on QC procedures.
- Collaborate with cross-functional teams to interpret project priorities.
- Maintain accurate documentation and complete tasks within defined timelines.
Required Skills & Experience
- Experience in GMP pharmaceutical or biotechnology QC laboratories
- Experience with Change Control, Deviations, CAPA, Investigations, and EICRs
- Hands-on experience with analytical testing and assay review
- Strong data analysis and interpretation skills
- Experience writing GMP documentation and validation protocols
- Ability to identify deviations from standard practices and resolve issues
- Strong written and verbal communication skills
- Ability to work independently and in a team environment
- Excellent prioritization and problem-solving skills
Laboratory Systems Experience (Preferred)
Experience with one or more of the following:
- SoftmaxPro
- Empower
- SoloVPE
- LIMS
- TrackWise
- Microsoft Office (Word, Excel, PowerPoint)
Experience with software validation activities, including:
- Writing validation documents
- Executing test scripts
- GMP system validation
Education
Associate’s Degree required in one of the following:
- Microbiology
- Biochemistry
- Biology
- Chemistry
- Other related life science field
Additional Qualifications
- Strong presentation and communication abilities
- Self-motivated with a positive team-oriented attitude
- Ability to manage multiple projects and deadlines
- Commitment to quality, compliance, and accuracy
Rohit Bohra
