Job Description:
With direct supervision, the candidate is responsible for the support and execution of QC laboratory equipment qualification activities while in full compliance with current cGMP regulations and Client principles, quality policies, standards, and core values. Maintains the company's right to operate, supply to patients, and cost-effectiveness by actively participating in continuous improvement projects.
Technical Responsibilities:
Perform qualification of laboratory equipment in accordance with EQ policies, plans, and procedures.
Coordinate with laboratory personnel to define qualification requirements.
Author, review, and execute equipment qualification protocols.
Coordinate equipment qualification activities with vendors and other support groups.
Identify business, quality, and compliance gaps.
Sign documents for activities as authorized and described by Client policies, procedures, and job descriptions.
Perform any other tasks as requested by Senior Management to support QC laboratory operations.
Requirements: BS/BA degree (preferably in a relevant scientific discipline).
Experience (may vary depending on site size/scope):
Experience in the pharmaceutical/biopharmaceutical industry, or an equivalent combination of education and experience.
Knowledge of cGMP or equivalent regulations.
Minimum of two years' experience in Validation or equipment qualification is desired.
Ability to make sound decisions about scheduling and managing priorities.
Flexibility in problem-solving, providing direction, and work hours to meet business objectives.
Knowledge / Skills / Competencies:
Possesses strong verbal and written communication skills and the ability to influence at all levels.
Capable of building trustful and effective relationships.
Able to think strategically and translate strategies into actionable plans.
Takes responsibility, drives results, and achieves expected outcomes.
Work Environment / Physical Demands / Safety Considerations:
Standard office environment.
