·Bachelor’s Degree in science, Chemistry (with current PR Chemist License preferred).
·Minimum of one to three (1-3) years of previous analytical service laboratory supervisory experience.
·Under the direction of the QC Laboratory Supervisor, the incumbent is responsible for the safe, efficient and effective operation of the laboratory areas on the assigned shift.
·This responsibility includes the testing of materials associated to their area (such as In-process, Raw Materials, Stability, and Finished Goods).
·Assists in the coordination of activities associated to the laboratory personnel and reviews test reports, as required. Ensure completion of Laboratory metrics.
·Participates in the hiring, training and development of Laboratory Analysts and Chemists.
·Reviews and approves protocols and reports, deviations, and any other documentation associated with the QC Laboratory, as required.
·Ensure site’s business continuity by providing on-time required Laboratory services.
·Puerto Rico Chemist License preferred.
·Willing to work rotating shifts.
·Fully bilingual; good oral and written communications skills in English and Spanish. Ability to read and interpret documents such as safety rules, personnel policies and procedures manuals.
Description
1.Assists in the coordination of the testing requirements associated with commercial and new products projects.
2.Participates in meetings associated with their area of responsibility, as required by the QC Laboratory Supervisor.
3.Review and/or revision of the applicable procedures, Quality Standard (QS), guidelines and policies, etc., as required.
4.Reviews and/or updates the sampling and testing plans of their area, as required.
5.Assists in the coordination of maintenance of adequate supplies of test solutions, reference standards, reagents chemicals and spare equipment by requesting these items in anticipation to their needs.
6.Reviews and/or prepares the necessary analytical reports associated with their area of responsibility.
7.Assures all personnel comply with GMP requirements in the QC Laboratory.
8.Revise and approves installation and qualification protocols for laboratory instruments
9.Provides personnel training related to Methods, pharmacopoeias and related documents changes, as required.
10.Under the direction of the QC Laboratory Supervisor, uses statistical methods to diagnose and correct improper quality control practices using analytical data to provide the best service and identify areas of opportunity and efficiency along with our clients.
11.Excellent interpersonal and good supervisory skills.
12.Manage multiple projects at the same time with minimum supervision and incorporate a wide array of technical principles, concepts and theories in innovative ways. Work under pressure, self–starter, demonstrates analytical and problem-solving skills.
13.Ability to teach others and transfer knowledge to end users.
14.Speaks effective and fluently to a group with the capacity to listen, understand information and ideas presented through spoken words and sentences.
15.Work cross functionally within an organization, being able to impact and influence other management teams that do not report to this position.
16.Possess regulatory (FDA) industry experience, familiarity with cGMP’s, GAMP (Good Automated Manufacturing Practice), Laboratory Equipment/Instrumentation C&Q practices (Commissioning & Qualification), EPA regulations, Laboratory safety, OSHA Rules, and control substances (DEA). Understand and resolve complex and critical QC analytical problems concurrent to Pharmacopeias requirements, changes and modifications.
17.Proven ability to learn new computer software/systems and laboratory instruments with minimum guidance and general understanding of SLC (system life cycle) and CSV (computer system validation).
18.Knowledge and experience with systems and validation processes.
19.Skills in MS Office Suite applications of MS Project, Outlook, Word, Excel and PowerPoint, skills at performing data evaluation, formulas and metrics.
20.Good organization and time management skills with the ability to adapt to changing priorities and to manage multiple assignments with challenging/conflicting deadlines.
21.Comply with all environmental trainings, procedures, guidelines, practices, current Good Manufacturing Practices (cGMP’s), permit conditions and internal notifications of any environmental event.
22.Able to move between areas.
23.Willing to travel (If required).
24.Maybe exposed to toxic substance in access-controlled areas.
25.Maybe exposed to closed areas.
26.Use the safety equipment accordingly to the restricted areas and products requirements.
Job Type: Temporary
