Reviews, interprets, and analyzes data for technical, quality and compliance to protocols, methods, SOPs, client criteria and Good Manufacturing Practices (GMP) and Good Laboratory Practices (GLP). Performs review of the data for accuracy and compliance with reporting requirements prior to submission to QA and issuance to customers. Verifies that calculations and documentation was performed per ALCOA principles. Understands testing protocols and ...
Follows, adheres and enforces GLP, GMP, GDP, USP, ICH guidelines, MedPharm procedures and Policies. Adheres to MedPharm Health & Safety Policy and OSHA regulations at all times and to ensure the safety of others in any procedures or tasks performed. Review of GLP quality related documents, including but not limited to study protocols and amendments, study reports, deviations, validation reports and other relevant documents as needed. Review and a...
Position Summary. The Executive Assistant will provide high-level administrative support to the CEO and other Executive Team members. The Executive Assistant must be creative and enjoy working in a fast-paced environment. The ideal individual will have the ability to exercise good judgment in a diversity of situations, with strong written and verbal communication, administrative, and organizational skills, and the ability to maintain a realistic ...
Operate manufacturing equipment and instruments. Complete assigned tasks in a timely manner. Lead daily assigned team. Provide management with performance operation updates and shift reports. Perform simple, routine, complex, and critical operations. Troubleshoot equipment issues, when necessary. Ensure process equipment is appropriately maintained for operation. Perform and document operations in accordance with cGMP’s. Execute equipment qualifi...
Reviews, interprets, and analyzes data for technical, quality and compliance to protocols, methods, SOPs, client criteria and Good Manufacturing Practices (GMP) and Good Laboratory Practices (GLP). Performs review of the data for accuracy and compliance with reporting requirements prior to submission to QA and issuance to customers. Verifies that calculations and documentation was performed per ALCOA principles. Verifies that all analyses are per...
Perform physical and chemical testing for topical formulations including but not limited to chromatography (GC and HPLC), particle size analysis, rheology, microscopy, and physical appearance. Ensure analytical testing of in-process, Drug Product (DP), stability samples and raw materials (API, excipients, and container closures) is performed according to GMP regulations. Performs laboratory work and peer reviews of analytical data in support of t...
Support Laboratory Quality Systems including change control, investigations, deviations, events, SOP revisions, and documentation practices as part of the quality and compliance objectives. Conduct investigations related to quality systems such as deviations, events, NCRs, CAPAs, OOS, NOEs, complaints, and Quality Protocols of high complexity. works closely with other members of the organization during investigations to determine root cause and p...
