Job Description: Oversees activities in the Quality Control Analytical Laboratory and assists with the testing of raw materials, packaging components, in-process products, finished products and stability samples. Performs duties and responsibilities to ensure that finished products, stability samples, and raw materials are tested in accordance with Quality Control Standard Operating Procedures (SOPs), and in compliance with FDA regulations.
Direct Reports: Quality Control Manager
Direct Supervision: None
Duties and Responsibilities:
- Plan, coordinate and direct the activities of the QC analysts to ensure continuous testing of raw materials, packaging components, finished product release and stability samples and in-process bulk product
- Review the implementation of updates Product Specification Forms
- Write reviews and oversee the implementation of Standard Operating Procedures
- Review Chromatography test data, stability testing data packages, worksheets, spec forms, and logbooks
- Investigate non-conforming (OOS) results in a timely manner and assists with CAPA reports
- Facilitate retrieval of analytical records during auditing processes
- Perform and oversees maintenance and cleaning of assigned HPLC, GC, and IC units and maintenance and update of associated equipment log books
- Coordinate activities with the Metrology Department for the routine maintenance and update of associated equipment logbooks
- Coordinate activities with the Meteorology Department for the routine maintenance and care of HPLC, IC, and GC Systems.
- Troubleshoot analytical instrumentation required for main analysis activities, either through the manufacturer’s manual guide or by placing the corresponding service call.
- Maintain operating supply level of laboratory consumables related to the analysis of stability samples
- Promote and endorses safety and security procedures in collaboration with the Safety Officer
- Observe and follows company guidelines, SOPs, policies, procedures, and FDA regulations
- Perform other duties inherent of the position, and additional duties that may be assigned by supervisor
- Extensive knowledge of the principle and operation of various equipment (HPLC, GC, AA, UV- VIS, Spectrophotometer, pH-Meter, viscometer, laboratory scales, etc.)
- Knowledge in wet chemistry
- Proficiency with computer and basic Microsoft Office software (Word, Excel, Access) or any other required software that supports daily activities
- Knowledge of the principles of cGMP and cGLP (current Good Manufacturing/ Laboratory Practices) as outlined by the DA
- Ability to be pro-active in order to anticipate potential needs that might affects the QC department activities
- Knowledge of arithmetic, stoichiometry, statistics, and other mathematical conversions of numbers
- Ability to use deductive and inductive reasoning in problem solving to come up with realistic answers
- Ability to use oral and written expressions to effectively communicate with other members if the organization
- Ability to anticipate potential problems so as to avoid an minimize out-of- specification investigations
- Synthesize complex or diverse information
- Pursue training and development opportunities; strive to continuously build knowledge and skills
- Write clearly and informatively; present numerical data effectively; read and interpret written information
- Exhibit sound and accurate judgment; demonstrate accuracy and thoroughness; ability to work independently.
- Observe safety and security procedures; report potentially unsafe conditions
- Use equipment and materials properly
- Bachelor of Science in Chemistry, or equivalent degree, with at least five (5) years of pertinent and related industrial experience.
- Trained and experienced with cGMP/cGLP
- Experience in automated HPLC and GC systems and chromatographic software
Physical Demands: While performing the duties of this Job, the employee is regularly required to stand, walk, use hands to finger, handle, or feel and to talk and hear.
Work Environment: While performing the duties of this job, the employee may be exposed to toxic or caustic chemicals and protective clothing or gear such as gloves and shoe covers may be required. The noise level in the work environment is usually moderate.
Eligibility Requirements: Prospective employees are required to prove that they are legally entitled to work in the United States. WDPrx verifies work eligibility and the identity of new hires according to rules established by the Department of Homeland Security (DHS) and the Social Security Administration (SSA). Original documentation is required to verify your eligibility to work in the U.S.
How to Apply: Send resume to firstname.lastname@example.org