Quality Specialist - Katalyst Healthcares & Life Sciences
Cleveland, OH 44101
About the Job
Responsibilities:
- Provide quality assurance oversight for C&Q, verification, and validation activities, ensuring compliance with GMP, FDA, and other regulatory requirements.
- Collaborate with engineering, operations, and IT teams to ensure the implementation of quality standards in automated and computer-controlled systems.
- Ensure all quality activities are conducted following applicable policies, procedures, and regulatory expectations.
- Support regulatory inspections and audits, providing documentation and responses as required.
- Lead and provide oversight for commissioning, qualification, and validation of warehouse equipment and systems.
- Review and approve validation documentation, including URS, FRS, IQ, OQ, and PQ protocols.
- Ensure appropriate risk-based approaches are applied to validation and verification activities.
- Monitor and assess changes to computerized systems and automated processes to ensure continued compliance.
- Identify opportunities for quality improvements and implement corrective and preventive actions (CAPAs).
- Support the development and implementation of quality systems, including change control, deviations, and investigations.
- Provide input into process optimization initiatives to enhance operational efficiency while maintaining compliance.
- Act as a quality advocate, providing guidance to project teams, suppliers, and stakeholders on quality and compliance matters.
- Participate in cross-functional project meetings to ensure quality considerations are integrated into project deliverables.
- Provide training and mentorship to team members on quality expectations and regulatory requirements.
- Bachelor's degree in a scientific field (Engineering, Biology, Chemistry, or related disciplines) or equivalent experience.
- Strong knowledge of pharmaceutical quality systems and GMP regulations, with experience in manufacturing environments.
- Previous experience with C&Q, verification, and validation oversight, particularly in automation and computer systems validation (CSV).
- Ability to work independently while collaborating with cross-functional teams to ensure compliance and quality objectives are met.
- Excellent documentation skills and attention to detail, with experience in writing and reviewing technical reports.
- Willingness to work 3 days per week on-site or 2 weeks on / 2 weeks off schedule.
- Experience with quality oversight in warehouse or logistics operations within pharmaceutical manufacturing.
- Knowledge of industry standards such as GAMP 5, 21 CFR Part 11, Annex 11, and relevant data integrity guidelines.
- Strong problem-solving and critical-thinking skills to address quality challenges proactively.
- Experience with electronic quality management systems (eQMS) and document control systems.
Source : Katalyst Healthcares & Life Sciences