What are the responsibilities and job description for the Quality Assurance position at Katalyst CRO?
Roles & Responsibilities
- Ensure the site validation program has been developed and maintained in compliance with all regulatory and corporate requirements and Master Plans.
- Works with the applicable qualification teams representing Quality Assurance in the requirement, design review, construction, qualification and leveraging documentation strategies, cleaning development/validation and implementation of project.
- Review and approve commissioning and qualification documentation, including URS (User Requirements Specifications), IQ (Installation Qualification), OQ (Operational Qualification), and PQ (Performance Qualification) protocols and reports, SOP's, Work Instructions and any other technical document.
- Review and approves validation protocols and reports (analytical, cleaning, process, etc.)
- Provide quality oversight for C&Q/CSV and validation execution activities to ensure compliance with GMP, FDA, EMA, and other regulatory requirements.
- Support the development and implementation of C&Q and validation plans, ensuring alignment with project timelines and deliverables.
- Perform QA reviews of system impact assessments and categorization of equipment and utilities.
- Ensure compliance with company quality standards, including SOPs, work instructions, and quality policies.
- Act as the QA point of contact for deviations, CAPAs, and change controls related to C&Q and validation activities.
- Provide recommendations for process improvements to enhance compliance and efficiency in C&Q and validation activities.
- Reviews/approves Technology Transfer documents assuring they meet regulatory and J&J requirements.
- Collaborate with cross-functional teams, including engineering, validation, and manufacturing, to address quality issues.
- Provides support and direction to all departments in respect of specific quality system elements to ensure business, quality and compliance goals are met following the J&J Standards.
- Partners with other Departments to ensure that compliance systems are implemented in an efficient manner.
- Develops and implements processes, procedures, forms, work instructions and tools related to the implementation of compliance systems at the site.
- Carries out tasks related to the administration of site nonconformance management, change control and training systems and its applicable Electronic Tracking System (ETS).
- Develops and implements processes, procedures and tools related to the implementation of compliance systems at the site.
- Collaborate with cross-functional teams (Operations, Engineering & Maintenance, MSAT, QC, etc) to address quality issues.
- Provides support to documentation review through evaluation and approval of documentation related to regulatory submissions, standard operating procedures (SOPs), and quality management systems to ensure accuracy and compliance as required.
- Bachelor's degree in a scientific or engineering discipline is required.
- Two to four (2-4) years of experience working within the biotherapeutic and/or pharmaceutical industry and knowledge in compliance of commissioning, qualification and validation of GMP processes and systems such as Utilities (water for injection, clean steam, process gases, HVAC, SIP/CIP), fridges, freezers, LAF, BSC units, autoclaves and isolators - as well as Process Equipment - Bioreactors, UF/DF, centrifuge, Chromatography systems.
- Strong understanding of cGMP, FDA, EMA, ICH guidelines, and ISPE Baseline Guides. Hands-on experience with qualification/validation lifecycle (URS, FAT, SAT, IQ, OQ, PQ) and cleaning/process validation.
- Familiarity with ISPE guidelines, including GAMP 5, ASTM E2500, and validation lifecycle principles.
- Strong understanding of risk-based approaches to commissioning and qualification/validation.
- Proficiency in technical writing for validation and quality documents.
- Strong communication and interpersonal skills for cross-functional collaboration.
- An unquestionable level of integrity and commitment to operating ethically and within the boundaries of regulatory requirements.
- Excellent communication and interpersonal skills, with the ability to effectively collaborate with cross-functional teams.
- Proven ability to manage multiple priorities and work independently with minimal supervision.
- Detail-oriented mindset, with a keen eye for identifying opportunities for process improvements.
- Proven ability to prioritize tasks and meet deadlines in a dynamic manufacturing environment.
- Ability to build and nurture strong and positive relationships.
- The ability to work in a team environment and interact with all levels of the organization.