To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skills, and/or abilities required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Education and/or Experience: Bachelor’s degree or higher is preferred but not required. Some college preferred. Experience and/or full knowledge of manufacturing operations, preparation of sterile injectables, aseptic processing and distribution of aseptic products is preferred. Knowledge of USP and FDA regulations is preferred. Have good knowledge of CGMP. Knowledge of how and ability to write, review and revise SOPs. Ability to read, write and speak English. Minimum of three years working in a CGMP (or equivalent) environment. Language Skills: Ability to read, analyze and interpret governmental regulations, general business periodicals, professional journals or technical procedures. Ability to read and interpret documents such as safety rules, operating and maintenance instructions, and procedure manuals. Ability to write reports, business correspondence and procedure manuals. Ability to effectively present information, deliver training and respond to questions from groups of managers, clients, customers and the general public. Reasoning Ability: Ability to define problems, collect data, establish facts and draw valid conclusions. Ability to problem-solve and handle issues. Computer Skills: Proficient in MS Office applications (Word, Excel, PowerPoint and Outlook), Very comfortable using the Internet and web browser interfaces for finding, accessing or logging information. Behavioral Characteristics: Strong interpersonal communication skills for interacting with site personnel, inspectors, and internal and external vendors required.. Facilitator. decision maker. Interact with all levels of personnel. Motivator. Ability to multi-task. Quick learner. Team attitude. Physical Demands: The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Close vision and focus capabilities to view computer screen, Company documents and correspondence. Ability to maneuver within a laboratory environment without placing self, product or others at risk.
Pharmaceutic Labs is a startup specialty pharmaceutical company looking for individuals who want to make a difference. Apply quality assurance (QA) processes and procedures at the site level to ensure product quality and regulatory compliance with 21 CFR Part 211 and related regulations and regulatory guidance. Participate and represent the site in corporate QA activities. The following are typical duties and responsibilities: •Oversight of the QA program and Quality Management System (QMS) at the site. The QMS at Pharmaceutic Labs is based on 21 CFR Part 211. •Write, review, approve or implement procedures, specifications, processes, and methods as required. •Oversee the examination and evaluation of each lot of incoming material before use to ensure that the material meets its established specifications. •Ensure that components, containers, closures, in-process materials, packaging materials, labeling, and finished dosage forms are examined and approved or rejected to ensure that all these meet their current specifications. •Ensure that personnel are properly trained and qualified, as appropriate. Ensure that the training and qualifications are properly documented. •Conduct periodic audits of own site to monitor compliance with established procedures and practices. May infrequently audit another site. •Liaise with internal and external inspectors and representatives, particularly on QA-related topics. •Oversee the metrology program at the site (i.e. equipment/personnel qualifications/validations, etc.) •Ensure manufacturing and analytical equipment is appropriately maintained and calibrated. Ensure applicable facility certifications are maintained. Identify to management facility and equipment problems requiring correction. •Review documents associated with the site’s QA program for completeness, errors and omissions. Review of executed CGMP records and product batch records to ensure compliance and product quality. •Review of trends (e.g. environmental monitoring, deviations, facility issues) to initiate corrective and preventive actions and/or for continuous improvement. •Continuous review of aseptic operations to ensure compliance to internal procedures (e.g.. gowning, cleaning/sanitation, sterility, environmental monitoring, etc.) and USP/FDA regulations •Ensure that all errors or omissions are reviewed. When it is determined that an investigation is appropriate, ensure an investigation is performed and documented, and corrective actions are taken to prevent the recurrence of the problem (CAPA, Deviations, OOS). Ensure any deviations from normal procedures are documented and justified. •Ensure compliance to all applicable standard operating procedures and regulations, including 21 CFR Part 211 requirements. Report and correct any deviations to internal procedures. Also, immediately report any unsafe conditions or potential or actual regulatory violations to management. •Ensure product complaints are handled in a manner consistent with Company SOPs and FDA regulations. •Oversee the site-level change control process. Ensure that changes in the laboratory are accepted or rejected as appropriate, and ensure the changes are appropriately documented. Initiate changes, including changes to SOPs, when appropriate, using the change control process. Assist and advise others at the site with initiating changes and following the change control process. •Attend quality related meetings and conference calls. Interface with corporate QA on quality related issues. Provide a status updates as required by corporate QA. •Assist as required with all other site QA activities not otherwise listed above.