Quality Control Chemist

Vacaville, CA - USA

Monthly Salary: Not Disclosed

Posted on: 3 hours ago

Vacancies: 1 Vacancy

Job Summary

Overview:

TekWissen is a global workforce management provider headquartered in Ann Arbor Michigan that offers strategic talent solutions to our clients world-wide. Our client is a leading biotechnology company that combines technological insight with world-class manufacturing scientific expertise and process excellence and helps their customers to deliver new and innovative medicines that help treat a wide range of diseases. Our client specializes in pharmaceutical ingredients Bioscience Biopharmaceuticals Custom manufacturing Biotechnology Life science ingredients Nutrition Microbial Control Agriculture Materials Science Personal Care and cell and gene therapy.

Job Title: Quality Control Chemist / QC Associate I
Location: Vacaville CA - 95688
Duration: 6 Months
Job Type: Temporary Assignment
Work Type: Onsite

Summary

With limited supervision the Quality Control Chemist / QC Associate I is responsible for performing direct materials testing in compliance with cGMP regulations. The role involves executing laboratory testing reviewing and trending data supporting investigations (OOS OOT OOE) and contributing to laboratory operations and quality objectives. The position works closely with Quality Control leadership to meet departmental and organizational goals.

Responsibilities

Perform basic to moderately complex laboratory testing in compliance with GMP requirements
Review analyze and assess test data against established acceptance criteria
Conduct technical review of peer-generated data
Perform trend analysis and assist in establishing limits
Identify discrepancies and support quality investigations and CAPA initiatives
Troubleshoot technical and testing-related issues
Identify gaps in systems procedures and laboratory practices
Participate in assay transfer assay validation and method-related activities
Perform equipment qualification calibration and routine maintenance
Prepare and maintain standards controls stocks cultures and reagents per procedures
Ensure GMP compliance across laboratory operations
Support internal and external audits and regulatory inspections
Coordinate with internal customers to support multi-site operations
Meet assigned schedules timelines and deadlines (95% on-time performance expectation)
Participate in or lead team projects process improvements and continuous improvement initiatives
Write protocols reports and technical documentation under limited supervision
Provide and receive training as required
Perform additional duties as assigned to support Quality activities

Required Skills

Bachelors degree (B.S./B.A.) in a relevant scientific discipline with 1 3 years of industry experience OR
Masters degree with at least 1 year of relevant experience
Experience in the pharmaceutical or biopharmaceutical industry
Hands-on experience with analytical and/or biological testing procedures
Strong understanding of cGMP regulations and quality systems
Experience with OOS OOT and OOE investigations
Exposure to assay transfer assay validation and method lifecycle activities
Experience supporting regulatory inspections (FDA EMA etc.)
Familiarity with trend analysis and data integrity practices
Prior involvement in process improvement or cross-functional projects
Experience working in multi-site or global operational environments
Ability to apply scientific principles theories and techniques in a QC environment
Strong verbal and written communication skills
Sound judgment analytical thinking and problem-solving abilities
Ability to work independently with limited supervision and manage short-term priorities

TekWissen Group is an equal opportunity employer supporting workforce diversity.

Overview: TekWissen is a global workforce management provider headquartered in Ann Arbor Michigan that offers strategic talent solutions to our clients world-wide. Our client is a leading biotechnology company that combines technological insight with world-class manufacturing scientific expertis...

Overview:

Job Title: Quality Control Chemist / QC Associate I
Location: Vacaville CA - 95688
Duration: 6 Months
Job Type: Temporary Assignment
Work Type: Onsite

Summary

Responsibilities

Perform basic to moderately complex laboratory testing in compliance with GMP requirements
Review analyze and assess test data against established acceptance criteria
Conduct technical review of peer-generated data
Perform trend analysis and assist in establishing limits
Identify discrepancies and support quality investigations and CAPA initiatives
Troubleshoot technical and testing-related issues
Identify gaps in systems procedures and laboratory practices
Participate in assay transfer assay validation and method-related activities
Perform equipment qualification calibration and routine maintenance
Prepare and maintain standards controls stocks cultures and reagents per procedures
Ensure GMP compliance across laboratory operations
Support internal and external audits and regulatory inspections
Coordinate with internal customers to support multi-site operations
Meet assigned schedules timelines and deadlines (95% on-time performance expectation)
Participate in or lead team projects process improvements and continuous improvement initiatives
Write protocols reports and technical documentation under limited supervision
Provide and receive training as required
Perform additional duties as assigned to support Quality activities

Required Skills

Bachelors degree (B.S./B.A.) in a relevant scientific discipline with 1 3 years of industry experience OR
Masters degree with at least 1 year of relevant experience
Experience in the pharmaceutical or biopharmaceutical industry
Hands-on experience with analytical and/or biological testing procedures
Strong understanding of cGMP regulations and quality systems
Experience with OOS OOT and OOE investigations
Exposure to assay transfer assay validation and method lifecycle activities
Experience supporting regulatory inspections (FDA EMA etc.)
Familiarity with trend analysis and data integrity practices
Prior involvement in process improvement or cross-functional projects
Experience working in multi-site or global operational environments
Ability to apply scientific principles theories and techniques in a QC environment
Strong verbal and written communication skills
Sound judgment analytical thinking and problem-solving abilities
Ability to work independently with limited supervision and manage short-term priorities