QC Validation Specialist

Vacaville, CA - USA

Monthly Salary: Not Disclosed

Posted on: 30+ days 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: Validation Engineer II / QC Validation Specialist

Location: Vacaville CA 95688

Duration: 6 Months

Job Type: Temporary Assignment

Work Type: Onsite

Shift: Monday to Friday from 08:00 AM to 04:00 PM

Summary

Under direct supervision the candidate is responsible for supporting and executing QC laboratory equipment qualification activities in compliance with current cGMP regulations and corporate principles quality policies standards and core values.
This role helps maintain the companys license to operate ensures reliable patient supply and contributes to cost-effectiveness by actively participating in continuous improvement projects.

Responsibilities

Perform qualification of laboratory equipment in alignment with EQ policies plans and procedures.
Collaborate with laboratory personnel to define equipment qualification requirements.
Author review and execute equipment qualification protocols.
Coordinate qualification activities with vendors and internal support groups.
Identify business quality and compliance gaps.
Sign documents for activities as authorized under company policies and job descriptions.
Perform additional tasks as requested by Senior Management to support QC laboratory operations.

Required Skills

BS/BA degree preferably in a relevant scientific discipline.
Experience in the pharmaceutical or biopharmaceutical industry or an equivalent combination of education and experience.
Knowledge of cGMP regulations (or equivalent).
Minimum 2 years experience in validation or equipment qualification.
Ability to make sound decisions on scheduling and managing priorities.
Flexibility in problem-solving providing direction and adjusting work hours to meet business needs.
Strong verbal and written communication skills.
Ability to influence across all levels of the organization.
Skilled at building trustful and effective relationships.
Strategic thinker with ability to translate strategies into actionable plans.
Strong sense of accountability results orientation and follow-through.

Desired Skills

Prior hands-on experience with QC laboratory equipment qualification.
Familiarity with vendor coordination for qualification activities.
Background in continuous improvement initiatives within QC labs.
Demonstrated ability to identify and resolve compliance or quality gaps proactively.

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 expert...