Chemist III

Location: Bedford, OH
Job Type: Full-Time
Req ID: 12694

About Us

As a developer, manufacturer, and supplier of essential medicines, Hikma Pharmaceuticals USA Inc. and its affiliates’ mission is to bring Better Health. Within Reach. Every Day.® for millions of patients around the world. We are a trusted, reliable partner and dependable source of over 800 high-quality generic, specialty and branded pharmaceutical products that hospitals, physicians and pharmacists need to treat their patients across North America, the Middle East, North Africa and Europe. Through our 32 manufacturing plants, eight R&D centers, and 9,500+ employees worldwide, we are always hard at work creating high-quality medicines and making them accessible to the people who need them.

Description

We are committed to building a diverse and inclusive team and encourage applications from candidates of all backgrounds. We are seeking a talented and motivated Chemist III to join our team. The Chemist III is part of Quality Control and is responsible for executing testing in the Chemistry laboratory at Bedford site in Hikma to include: TOC and Conductivity for WFI, Nitrates via wet methods, identification by FTIR, chromatography analysis, in-process testing by instrumental and wet chemistry techniques, and learning any other new testing capabilities within QC Laboratory Operations. The Chemist III is also responsible for designing test protocol for equipment and method qualification/validation activities. Furthermore, the Chemist III is responsible for writing quality records as needed and documenting all work according to cGMP and cGLP standards. Chemist III is responsible for designing training program for simple to complex Chemistry analysis, and training Chemist I-II, or QC Laboratory Technician to execute routine laboratory testing.

Key Responsibilities

• Ensure the laboratory is kept in a safe working environment and in compliance with OSHA and other laboratory safety standards.
• Perform TOC and Conductivity for WFI, Nitrates via wet methods, identification by FTIR, Karl Fischer Titration, chromatography analysis, in-process testing by instrumental and wet chemistry techniques. Participate in introducing new laboratory capabilities within QC Laboratory Operations.
• Support the QC Equipment Validation and Calibration Programs for the site. Ensure the systems are robust and compliant with current industry practices and cGMP/cGLP requirements.
• With minimal supervision able to qualify laboratory equipment to include authoring and execution of IQ/OQ/PQ protocols and reports.
• Conduct testing in support of method validation/verification, method and tech transfer, routine and non-routine testing as part of investigation support.
• Serve as point of contact for specified laboratory workflow (e.g. SOPs, test procedures, method/equipment validation, reports, logbooks, laboratory metrics evaluation, etc.) and coordinate activities with Analytical Chemists to meet specified due date.
• Review and approve laboratory test data, SOP’s, test procedures, method/equipment validation protocols and reports.
• Perform laboratory cleaning routinely in preparation of laboratory inspections including regulatory inspections and to ensure good housekeeping is followed.
• Able to execute test methods according to regulatory guidance such as USP/EP, using appropriate analysis protocol as guidance.
• Provide support in laboratory metrics maintenance, and provide recommendation for continuous improvement in QC Laboratory. Participate in implementation initiatives as needed.
• Document all work performed according to applicable Current Good Documentation Practices and cGLP’s.
• Recommend and initiate preventive and corrective action with regard to product non-conformances and quality system activities as they relate to the Chemistry laboratory activities.
• Support activities associated with investigations related to cGLP and cGMP analytical processes for Hikma Pharmaceuticals.
• Independently initiate and author laboratory investigations as needed.
• Manage and escalate Quality issues to QC Manager, or appropriate designee.
• Train and coach Chemist I-II or QC Laboratory Technician to perform lab testing using applicable OJT documents.
• Author OJT, SOPs, testing protocol for Chemistry Analysis at simple to complex level.
• Ensure processes and products are in compliance with all local, state, and federal rules and regulations.
• Personnel engaged in the manufacture, processing, packing, or holding of a drug product shall wear clean clothing appropriate for the duties they perform. Protective apparel, such as head, face, hand, and arm coverings, shall be worn as necessary to protect drug products from contamination.
• Ensures the laboratory is kept in a safe working environment and in compliance with OSHA and other laboratory safety standards.
• Maintains knowledge of the latest guidelines of regulatory requirements of International Conference of Harmonization, compendia, USFDA and OSHA. Support the update of methods and instrument qualifications accordingly.
• Maintain a clean work environment with regards to cleaning schedules and good housekeeping standards.
• Perform additional tasks in relation to quality issues as agreed with the QC Manager.