QC Equipment Qualification Specialist

Katalyst-Healthcares-; Augusta (GA); On-site; USD 60,000 - 90,000; Full time

Job summary

Creative Solutions Services, LLC is seeking a QC Laboratory Equipment Qualification Associate to support cGMP-compliant qualification activities under supervision. You will help ensure equipment readiness, maintain documentation, and participate in continuous improvement of QC operations.

The role requires a BS/BA in a relevant science, 2 years in validation or equipment qualification, and solid written and verbal communication to interact with internal teams and vendors.

Qualifications

• BS/BA degree in a relevant scientific discipline.
• Experience in pharmaceutical/biopharmaceutical industry or equivalent.
• Knowledge of cGMP regulations.
• Minimum of two years in validation or equipment qualification.
• Ability to schedule and prioritize work.

Responsibilities

• Qualify laboratory equipment per EQ policies and procedures.
• Coordinate with laboratory personnel to define qualification requirements.
• Author, review, and execute equipment qualification protocols.
• Coordinate activities with vendors and support groups.
• Identify business, quality, and compliance gaps.
• Sign documents as authorized by Client policies and procedures.
• Support QC laboratory operations per senior management.

Skills

cGMP experience

Quality systems

Equipment qualification

Documentation

Communication

Education

Bachelor's degree in life sciences

Job description

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:
Education:

• 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.