QC Analyst I

Vacaville, CA - USA

Monthly Salary: Not Disclosed

Posted on: 10 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: QC Analyst

Location: Vacaville CA

Duration: 6 months

Job Type: Temporary Position

Work Type: Onsite

Summary

The QC Stability Study Coordinator I is responsible for overseeing stability program management in compliance with cGMP regulations with limited supervision. This role includes execution of trend analysis documentation review deviation support (OOS OOT OOE) and general laboratory support activities. The coordinator works closely with Quality Control leadership to achieve departmental and organizational objectives.

Key Accountabilities:

Review analytical data against established acceptance criteria
Perform technical review of peer-generated data
Evaluate data to identify trends and establish limits
Conduct routine and non-routine Out of Trend (OOT) linear regression assessments
Support deviations including OOS OOT and OOE investigations
Provide input into quality investigations and CAPA initiatives
Identify and troubleshoot technical issues
Identify gaps in systems and procedures
Develop Stability Protocols
Conduct stability deviation assessments
Create and review Routine Master Data Testing
Assist in Annual Product Quality Reviews (APQRs) authoring
Support time point approval activities
Manage change control documentation
Handle data table requests and annual report requests (including client monitor requests)
Participate in stability-related projects and process improvement initiatives
Perform data entry and review
Support training coordination
Maintain GMP compliance in all operational areas
Coordinate with customers for multi-site operational support
Support internal audits external audits and regulatory inspections
Work effectively to meet schedules timelines and deadlines
Participate in and/or lead cross-functional project teams
Perform additional quality-related duties as assigned

Required Qualifications

B.S./B.A. degree in a relevant scientific discipline
1 3 years of experience in the pharmaceutical or biopharmaceutical industry (or equivalent combination of education and experience)
Knowledge of cGMP regulations and quality systems
Experience in stability program management
Exposure to regulatory inspections and audit support
Experience with CAPA deviation investigations and change control processes
Knowledge of trend analysis and statistical data evaluation
Experience supporting multi-site operations
Familiarity with APQR documentation and authoring support
Strong verbal and written communication skills
Ability to organize and present information formally and informally
Working knowledge of scientific theories principles and analytical/biological testing techniques
Strong problem-solving reasoning and analytical skills
Ability to exercise sound judgment
Capable of working independently with limited supervision
Ability to prioritize short-term tasks effectively

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...