Overall Responsibilities:
Supervise the laboratory team to achieve the established objectives and goals on a timely manner.
Oversee the laboratory operations including control of the laboratory data/ results versus internal procedures, test methods and specifications, monitor the personnel performance in terms of quantity and quality of work, drive team for completion of new projects, monitor procedures and equipment performance in terms to the laboratory operations and business needs.
Review and/or verify the laboratory data/ results for accuracy and completeness as required per applicable procedures and/or test methods. Review chemical and physical testing data/ reports ensuring that materials/ products are tested in compliance with company specifications, policies and government regulations. Conduct internal audits (e.g. log books).
Perform contemporary recording of laboratory data in respective logbooks, forms, laboratory work sheets, and/or computer systems, and supervise that team members follow these documentation practices.
Recommend purchase of instrumentation and assist/ implement changes in procedures to meets the goals to effectively utilize personnel.
Assist management in department planning. Perform the weekly testing schedule and assign the tests according to manufacturing and /or stability requirements or product deadlines. Attend to meetings and plan the laboratory tasks of the team in coordination with the Planning Department schedules to comply with business needs and metrics. Conduct lot disposition to meet the area performance metrics.
Assist the QC Manager in hiring of laboratory personnel. Plan and perform or supervise the training process of the laboratory personnel.
Preferred Qualifications:
Minimum of a Bachelor's degree in Chemist (or equivalent) and 2-4 years of experience in the Pharmaceutical Industry. Experience in analytical techniques within the Pharmaceuticals Industry. Experience in the use and troubleshooting of instrumentation such as HPLC, FTIR, UV, GC and computers. Experience in technical writing and writing/ generation of laboratory investigations. However, a combination of experience and/or education will be taken into consideration. Must possess knowledge of Standard Operating Procedures, Laboratory Procedures, USP regulations, Product Testing Procedures, cGMP, OSHA regulations/procedures for disposal or organic waste, and procedures for the safe handling of chemicals. Comprehension of industry, LIMS knowledge preferred.
LICENSES/CERTIFICATIONS
Puerto Rico Chemist License issued by the Puerto Rico State Department.
Job Type: Full-time
