The Specialist I, Lab Compliance - QC is responsible for developing, managing, and implementing the laboratory compliance and data integrity program for the site to ensure compliance with local and global regulatory agency requirements, internal company standards, and current industry practices. This role will support overall laboratory compliance including but not limited to GLP, GxP, Data Governance/Integrity programs for site laboratory operations (sample receipt through sample disposition) and all laboratory systems as prescribed in Global Quality Standard (GQS) policies and site standard operation procedures across system validation lifecycles for assurance with regulatory and compliance requirements.
Essential Functions:
Perform periodic review of electronic data and audit trail of chromatographic and non-chromatographic systems. Review Aborted and Altered sample set in chromatographic systems audit trail for proper comments and same notation in the laboratory notebook.
Perform periodic review of laboratory analysis for completeness, specification compliance, and data integrity with company’s written policies. Report any abnormal findings to their Supervisor. As assigned, perform in-depth review of analytical records/reports including laboratory notebook, chromatograms, and audit trails to assure that calculations and other data are technically correct and compliant to relevant specifications.
Perform periodic auditing of the laboratory systems (sample management, stability program, metrology program, glassware management; reference standard, chemicals, and column management, etc.)
Actively participate in process improvement initiatives aiming for Right First Time (RFT) on documentation and deviation reduction in collaboration with Quality Management teams
Perform periodic auditing of the laboratory investigations (unplanned deviations, OOALs/ OOTs, and incidents) to ensure investigations are carried out in accordance with he applicable SOPs/guidance.
Continuously improve data integrity knowledge base and understanding: Identify training needs, and ensure availability of appropriate and functionally relevant training materials; where training does not exist, facilitate creation of material and delivery of training
Education:
Bachelors Degree (BA/BS) Chemistry or related science discipline - Required
Experience:
4 years or more in Pharmaceutical and/or life sciences experience including 21 CFR Part 11 and general GxP experience
4 years or more in Testing of chemicals/pharmaceutical products
Skills:
Must be precise and consistent in day to day analysis, easily trainable and ready to learn. - Advanced
Must be able to work in a team environment and be flexible to easily adapt to changes in assignments. - Advanced
Must be able to execute compendial procedures involving complexity with no or minimal supervision. - Intermediate
Must be able to effectively communicate results, problems or issues, verbally as well as in writing. - Advanced
Must be able to assume a role of a leader in team environment as and when required. - Advanced
Must be computer literate and savvy with MS office applications, software programs related to LIMS. - Advanced
Must be willing to work extended hours, including weekends, as and when required. - Advanced
Must follow safe practices as identified in appropriate MSDS during working with chemicals, and must follow applicable state and federal regulations. - Advanced
Must be capable of maintaining clear and concise laboratory records and communicating clearly both within and between departments. - Intermediate
Must be thoroughly familiar with cGMP applicable to laboratories in pharmaceutical settings and with method verification/validation concepts. - Intermediate
Must be able to review laboratory records to ascertain compliance with applicable specifications, methods, and SOPs. - Intermediate
Specialized Knowledge:
Must possess in-depth knowledge of analytical chemistry techniques, such as spectrophotometric, dissolution and drug release, chromatographic techniques (standalone or hypenated) and measuring physical parameters (viscosity, particle size or droplet size by laser diffraction, melting point by DSC). Must be able to follow compendial (USP/EP/BP/JP) procedures for analysis.
Must understand and apply cGMP requirements applicable to quality control laboratory. Must have ability to apply advanced technical skills to troubleshoot and resolve complex analytical and instrument-related problems effectively and in a timely manner and report actions to the laboratory management in a timely manner.
Must be able to identify trends in analytical data.
Amneal is an Equal Opportunity Employer that does not discriminate on the basis of sex, age, race, color, creed, religion, national origin, sexual orientation, gender identity, genetic information, disability, veteran status, liability for service in the U.S. Armed Forces or any other characteristic protected by applicable federal, state, or local laws.
