Responsibilities will include:
The Sr. R&D QA Specialist is responsible for ensuring Quality Assurance compliance and supporting GMP operations for R&D. Primary responsibilities include administrating Quality Assurance functions/processes and interpretation and application of Quality Assurance and cGMP compliance requirements to R&D processes and procedures. Sr. R&D QA Specialist provides Technical and Organizational support to the Analytical Development, Product Development and First to File teams. The Sr. R&D QA Specialist must be capable of working with individuals at all levels within the organization.
•Identifies the need for investigations, reviews investigations, evaluates quality impact, tracks deadlines and performs trending of the investigations
•Initiates change requests related to CAPA or process improvement, evaluates for thoroughness and ensures CAPA timely closure
•Reviews and approves R&D trackwise and QUMAS change controls
•Maintains QA records (i.e. logbooks, reports, equipment qualification, batch records etc,) as required by established quality systems. Audits R&D records/reports to ensure compliance with GMP’s and 21 CFR part 211. Ensures PAI readiness for filed projects and assist in FDA PAIs
•Reviews batches for packaging, bio-studies, and ANDA submissions. Notifies of batch status to R&D QA and R&D management
•Approves product Master Formulae, Exhibit Batch and Cleaning Verification Protocols and Reports Performs in-process testing during the manufacturing process and equipment clearances.
•Approves Method Validation Reports, Technical Reports, COAs, Reference Standard Reports, Formulation Development Reports, Equipment Qualifications (Protocols and Reports) and releases into service
•Identifies quality/compliance issues, notifies management, and ensures investigations are performed, if needed.
•Conduct QA Audits of the Analytical Development laboratories and the Pilot Plant area.
•Provides training to other QA Specialist(s).
•Write, review, approve and maintain R&D (Analytical Development, Fomulation Development and QA) SOPs.
•Guide AD/FD on development and preparation of quality reports/ and or documentation.
•Minimum of 4 years in GMP environment, preferably in Analytical Development or Quality Control.
•Strong working knowledge of cGMPs and Analytical Development
•Excellent oral and written communication skills
•Must be proficient computer application user and highly organized
•Willingness and ability to work flexible schedule as needed is required
•Ability to travel (up to approximately 20%)
•Ability to work on personal computer for periods of time
•Work in office environment including light lifting, sitting, standing and walking as required
•Bachelor’s Degree in Chemistry or equivalent