Senior QC Laboratory Analyst

TekWissen Group is a workforce management provider throughout the USA and many other countries worldwide. This assignment is for a client specializing in biotechnology product development services that supplies laboratory equipment, chemicals, supplies, and services essential in healthcare, scientific research, safety, and education. As the global leader in serving the field of science, the client empowers customers to make the world healthier, cleaner, and safer, boasting an annual revenue of around $40 billion.

About the role

The QC Analyst IV will be a team member of the Quality Control department supporting the production of in-process and final product drug lots for customers. The role will also participate in quality testing for ongoing customer stability studies while providing on-time, high-quality results to meet manufacturing demands. This position applies job skills and company policies to complete a variety of tasks, may be assigned special projects, and may provide support to others in the absence of the supervisor/manager.

Responsibilities

• Provide feedback to junior analysts and offer guidance to co-workers with respect to compliance.
• Delegate tasks to support daily operations.
• Maintain laboratory equipment, working with maintenance, calibration, and vendors to ensure readiness for next use.
• Operate and troubleshoot laboratory equipment including pH/conductivity meters, Agilent and Waters HPLC systems, UPLC systems, pipettes, SoloVPE and Cary 60 spectrophotometers, PA-800 capillary electrophoresis instruments, Protein Simple iCE3/icIEF instruments, 7500 Real Time PCR systems, KingFisher Flex instruments, and Sysmex CS-2500 instruments.
• Perform quality review of quality and vendor binders.
• Train for assay execution and review within the HPLC Analytical Lab and Electrophoresis Lab, with the ability to cross-train into Immunology as applicable.
• Run and review advanced assays as necessary.
• Identify areas of improvement and work to implement them, including 6S, document revisions, work orders, and change controls.
• Communicate with other departments (MFG, QA, MSAT) during operations and escalate issues as needed.
• Initiate and assist with investigations as required within job functions.
• Drive audit readiness on the team with advanced regulatory knowledge.
• Conduct pre-audit walkthroughs through the laboratory space.
• Confidently and competently speak to auditors as a QC subject matter expert.
• Apply Data Integrity principles in all aspects of work, in compliance with DI policies, guidelines, and procedures.
• Complete assigned tasks on-time and accurately, identify needed tasks, and complete them without direction.
• Perform other duties as assigned.

Requirements

• Bachelor’s Degree in Biochemistry or a related science field.
• 5–10 years of industry experience, preferably in a cGMP environment (a combination of education and experience will be considered).
• Ability to comprehend and follow instructions and exercise judgment within defined procedures and practices.
• Strong ability to interpret data independently and with guidance.
• Strong written and verbal communication skills.
• Self-motivated team player with the ability to relate to others in a team environment.
• Positive and professional attitude within the team environment.
• Ability to complete assignments on-time and accurately, with minimal re-work.
• Commitment to quality and ability to perform job functions to the best of their ability.
• Ability to perform assigned, complex, and/or varied tasks.
• Strong prioritization and problem-solving skills.
• Ability to direct, control, and plan tasks/projects.

Pay

$45 to $50 per hour

Schedule

• 8-month temporary assignment
• Onsite in Portsmouth, NH (03801)