Quality Systems Specialist (Pharmaceutical Validation)

12-month temporary contract role.

About the role

Quality Systems Specialist (Pharmaceutical Validation & Compliance) responsible for writing, reviewing, approving, and executing documentation related to validation procedures, technical reports, and quality systems in a cGMP-regulated pharmaceutical environment.

Responsibilities

• Maintain a thorough understanding of FDA, CLIA, cGMP, corporate policies, FDA validation guidance, Medical Device Directives, and other applicable standards.
• Assist in preparation, execution, data collection, and reporting of validation studies to ensure user needs and specifications are consistently met.
• Prepare validation protocols and test equipment; evaluate validation test data.
• Prepare reports summarizing test results and their conformance to defined acceptance criteria.
• Assist in developing programs and maintaining standard operating procedures (SOPs) validations.
• Provide support related to management of procedural documents.
• Communicate cross-functionally regarding needs and status of assigned study activities and project deliverables.
• Verify calibration, maintenance, and repair of instruments supporting the Quality Systems validation program.
• Ensure corrective measures meet acceptable reliability standards.
• Conduct quality control for statistical analyses of testing results and process anomalies.
• Participate in FMEA or RCA/CAPA development teams.
• Perform other job-related duties as assigned.

Requirements

• Bachelor’s Degree in Sciences or Engineering or equivalent combination of education, training, and relevant work experience.
• 0–3 years’ related quality/validation experience in pharmaceutical manufacturing or a highly regulated industry.
• In-depth working knowledge of cGMP principles and applications.
• Demonstrated ability writing and approving documents that explain technologies, processes, and products, including validations.
• Understanding of regulatory standards and applicable local, state, and federal laws.
• Excellent negotiating, critical reasoning, decision-making, and problem-solving skills.
• Strong project management and organizational skills with keen attention to detail.
• Strong written and verbal communication, interpersonal, and presentation skills.
• Ability to establish solid working relationships across business units, third parties, and within the organization.
• Excellent customer service skills with flexibility to respond to changes quickly.
• Professional demeanor and ability to handle confidential information with discretion.
• Computer literate with proficiency in office applications, word processing, spreadsheets, graphics, statistical programs, and electronic quality/operational systems.
• Ability to understand complex problems, collaborate, and explore alternative solutions.
• Ability to make decisions with significant impact on the immediate work unit and monitor impact outside the unit.
• Attention to detail and ability to follow written and verbal directions precisely.

Qualifications

• ASQ Certification preferred.

Pay

Hourly pay rate: $32.00 – $35.00.

Schedule

12-month temporary contract.