QC Analyst IV sgs-job-5817 Business Support New Hampshire

Quality Control

Biologics

cGMP

HPLC

UPLC

Electrophoresis

Data Integrity

QC Testing Contract - 8 Months Portsmouth, NH 03801 Serve as a hands-on senior member of the Quality Control team supporting testing of in-process materials, finished drug products, stability samples, ad hoc testing, and client-specific requests in a biologics manufacturing environment. Perform and review analytical assays, troubleshoot laboratory equipment and software, support investigations and audit readiness, and ensure accurate, timely, and compliant QC results. Provide technical guidance and feedback to junior analysts, delegate daily tasks, and help drive laboratory improvements without serving as a formal manager.

Job Responsibilities:

• Perform hands-on QC testing of in-process materials, finished products, stability samples, ad hoc requests, and client-specific samples.
• Support production of in-process and final product drug lots by delivering accurate, timely, and high-quality analytical results.
• Provide technical guidance, feedback, and compliance support to junior QC analysts.
• Delegate daily laboratory tasks to support efficient team operations.
• Train and cross-train analysts on applicable laboratory assays and analytical procedures.
• Perform and review assays within HPLC Analytical and Electrophoresis laboratories.
• Support cross-training into Immunology and advanced analytical assays as required.
• Operate, maintain, troubleshoot, and support qualification/calibration activities for laboratory equipment.
• Work with maintenance, calibration teams, and equipment vendors to ensure instruments are maintained and available for use.

Support equipment including pH/conductivity meters, Agilent and Waters HPLC systems, UPLC systems, pipettes, SoloVPE and Cary 60 spectrophotometers, PA-800 capillary electrophoresis instruments, ProteinSimple iCE3/icIEF systems, 7500 Real-Time PCR systems, KingFisher Flex instruments, and Sysmex CS-2500 systems.

Review laboratory equipment and vendor quality binders for completeness and compliance.

Troubleshoot laboratory equipment, software, and analytical issues and escalate complex problems as appropriate.

Identify opportunities for laboratory and process improvements, including 6S activities, document revisions, work orders, and change controls.

Collaborate with Manufacturing, Quality Assurance, MSAT, Process Validation, QC Biochemistry, and other cross-functional teams during operations.

Initiate and support investigations related to QC testing, equipment, analytical results, and laboratory operations.

Support audit readiness activities and conduct pre-audit walkthroughs of laboratory areas.

Serve as a QC subject matter expert during regulatory and quality audits and confidently communicate with auditors.

Apply Data Integrity principles to all laboratory activities in accordance with applicable policies, guidelines, and procedures.

Ensure all assigned testing, documentation, reviews, and other activities are completed accurately and on schedule.

Independently identify required tasks and complete assignments with minimal direction.

Prioritize and manage multiple laboratory activities while maintaining quality and compliance requirements.

Follow cGMP, safety, quality, and site procedures at all times.

Promptly communicate regulatory inspections, GMP deficiencies, process deviations, product defects, and other quality concerns to management.

Promote a positive, professional, and collaborative laboratory environment.

Support additional QC projects and responsibilities as assigned.

Skills:

Quality Control (QC)

Biologics

cGMP

GMP Documentation

In-Process and Finished Goods Testing

Stability Testing

HPLC

UPLC

Capillary Electrophoresis

Protein Electrophoresis

Immunology Assays

Analytical Testing

Assay Execution and Review

Data Integrity

Laboratory Equipment Troubleshooting

Laboratory Instrumentation

Agilent HPLC

Waters HPLC

ProteinSimple iCE3/icIEF

PA-800 Capillary Electrophoresis

Cary 60 Spectrophotometer

SoloVPE

Real-Time PCR

KingFisher Flex

Sysmex CS-2500

Laboratory Investigations

Audit Readiness

Regulatory Compliance

Change Controls

Work Orders

6S / Continuous Improvement

Quality Systems

Data Analysis

Technical Documentation

Team Guidance and Training

Problem Solving

Cross-Functional Collaboration

Education/Experience:

Ability to interpret analytical data and make appropriate quality decisions within established procedures.

Strong written and verbal communication skills.

Bachelor's degree in Biochemistry or a related scientific field required.

Combination of education and relevant experience may be considered.

Approximately 5-10 years of relevant industry experience, preferably in a cGMP-regulated environment.

Extensive hands-on laboratory experience in a biologics environment strongly preferred.

Experience performing QC testing on in-process materials, finished goods, stability samples, or client-requested samples preferred.

Strong experience with HPLC and/or electrophoresis analytical laboratories.

Ability to perform and review analytical assays and support advanced testing activities.

Experience troubleshooting laboratory instruments and software.

Strong understanding of cGMP requirements and Data Integrity principles.

Experience supporting laboratory investigations, audit readiness, and regulatory inspections.