Senior Quality Control Analyst

Portsmouth, OH - USA

Monthly Salary: Not Disclosed

Posted on: 7 hours ago

Vacancies: 1 Vacancy

Job Summary

Overview:

TekWissen group is a workforce management provider throughout the USA and many other countries in the world. Our client is a leading biotechnology company that combines technological expertise with world-class manufacturing and scientific insight to support the delivery of innovative medicines for a wide range of diseases. Specializing in pharmaceutical ingredients bioscience biopharmaceuticals custom manufacturing and cell and gene therapy the company provides comprehensive services across the pharmaceutical biotech and life sciences sectors. It supports every stage of drug development from early research to commercial production and offers solutions in biologics small molecules and specialty ingredients. Committed to quality and innovation the company serves as a critical partner in advancing therapeutic solutions and streamlining complex manufacturing processes with a global presence that ensures access to scalable flexible and compliant technical expertise.

Job Title: Senior Quality Control Analyst

Location: Portsmouth NH - 03801

Duration: 12 Months

Job Type: Temporary Position

Work Type: Onsite

Summary

The Quality Control Technical Transfer Analyst 3 is responsible for supporting production by contributing to technical transfer activities within the Quality Control department. The role also supports quality testing activities including in-process testing final product testing and stability studies. The analyst applies job skills company policies and procedures to complete a variety of semi-routine tasks and works on assignments of moderate scope requiring data analysis and identification of deviations from standard practices.

Responsibilities

Support technical transfer activities within the Quality Control department.
Perform quality testing for in-process lot release and stability studies.
Run test samples for investigations method transfers and validations.
Review assays and ensure accuracy of results.
Assist with training other team members.
Write and maintain quality records including deviations CAPAs and change control documentation.
Participate in projects such as method transfers new instrument implementation and method qualifications.
Use laboratory computer systems and software for testing and documentation.
Apply Data Integrity (DI) principles in compliance with company policies and procedures.
Conduct root cause analysis for software or testing issues when necessary.
Communicate with cross-functional teams to understand priorities and requirements.
Maintain compliance with GMP and internal quality standards.
Remain up to date with required training activities.
Perform other duties as assigned.

Required Qualifications

Associates Degree in Microbiology Biochemistry or a related science field.
Experience with laboratory software such as SoftmaxPro Empower SoloVPE is required
Experience with GMP Quality Systems such as TrackWise and or LIMS is required
Experience working in a GMP environment within the pharmaceutical industry.
Experience with Change Control Deviations CAPAs Tasks EICRs and Investigations.
Experience writing GMP documentation including procedures and validation documents.
Experience performing software validation including executing test scripts.
Ability to act as a Subject Matter Expert (SME) for at least one software system.
Experience participating in method transfers and instrument qualification projects.
Strong public speaking and presentation abilities.
Demonstrated ability to lead tasks and coordinate projects.
Self-motivated detail-oriented and able to meet deadlines consistently.
Ability to run laboratory tests for in-process lot release and stability samples.
Strong ability to interpret and analyze data.
Knowledge of Data Integrity principles and compliance practices.
Strong written and verbal communication skills.
Ability to prioritize tasks and solve problems effectively.
Ability to work independently and within a team environment.
Proficiency in Microsoft Office Suite (Word Excel PowerPoint).
Experience with laboratory computer systems.

TekWissen Group is an equal opportunity employer supporting workforce diversity.

Overview: TekWissen group is a workforce management provider throughout the USA and many other countries in the world. Our client is a leading biotechnology company that combines technological expertise with world-class manufacturing and scientific insight to support the delivery of innovativ...