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Chemistry ManagerBookmark This
Posted: November 15 2016
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REPORTS TO: Plant QA Manager
SUMMARY OF POSITION:
Directs the functioning of the chemistry laboratory and the day to day activities of chemistry laboratory personnel to provide accurate and timely testing, release of raw materials and finished product, and insures procedural compliance to cGMP, GLP, and FDA regulation.
1. Directs the activities of chemistry personnel for routine production support and for the testing or raw materials, in-process samples, and finished product.
2. Reviews and approves the release of raw materials, in-process samples, and finished goods for compliance to established procedures and regulations.
3. Performs weekly and monthly team meeting to address safety, GMP/GLP/FDA, and plant communications.
4. Develops and revises new or existing procedures and methods to insure compliance to cGMP, GLP, and FDA regulations.
5. Directs laboratory instrumentation and process validation studies, writing protocols, and documenting results.
6. Coordinates training program for both new and existing team members to insure compliance to training requirements mandated by FDA regulations.
7. Controls lab costs and overtime requirements within budget restraints while still maintaining quality support to both internal and external customers.
8. Assigns monitoring of plant systems and reviews results and documentation for compliance and control.
9. Insures laboratory maintains audit ready status by implementing procedures to perform internal audits in order to prevent non-compliance occurrence.
10. Responsible for the implementation of new projects and testing methods to improve laboratory operation and reduce costs.
11. Eliminates recordable and loss time incidents in the laboratory through requirement of employee participation in the plant safety and awareness program and by evaluating current conditions and practices.
12. Completes employee performance review to evaluate their job performance and make recommendations to increase job satisfaction and progress career development.
13. Performs other supervisory responsibilities in the absence of other Quality team members.
14. Supports the testing and release of raw materials and finished goods.
DEPARTMENT SPECIFIC/NON-ESSENTIAL FUNCTIONS:
1. Enforce EHS procedures and respond to EHS concerns within his/her area of operational responsibility. Perform incident investigations and follow through regarding corrective actions.
2. Work safely in accordance with regulations, standards, and procedures and in a manner that eliminates unreasonable risk to health and the environment. Notify management of unsafe conditions or practices, unlawful activities and activities which present unreasonable health and/or environmental risk. Report all safety and/or environmental incidents to management immediately.
3. Other duties as assigned with or without accommodation.
Education required/ preferred:
BS or higher degree in Chemistry (preferred) or other science with General, Organic, and Analytical chemistry coursework.
3-5 years of Analytical Chemistry testing or Quality Assurance experience in a FDA regulated environment with 2-3 years in a supervisory position
Working knowledge of cGMP, GLP, and FDA regulations
Knowledge of typical analytical laboratory equipment
Self-motivated, energetic, enthusiastic, and team oriented
Requires the ability to apply analytical and scientific principles for solving problems and for properly analyzing and reporting laboratory data
Effective communication with both team members and other plant support groups
· Position reports to Plant QA Manager.
· Directly supervises 1st and 2nd shift Chemistry Lab personnel.
· Assumes responsibility for resolving problem situations at the highest level, involving management as necessary.
· Responsible for making routine decisions and informing Quality and Plant management of significant developments as they occur
· Possesses deepest sense of personal responsibility in order to provide support to both internal and external customers. Interaction with corporate R&D, and site manufacturing personnel as well as external regulatory inspectors where appropriate.
· Observes and reports to Quality and Plant management variations in testing results, sample conditions, specifications/procedures, analyst technique, equipment/instrumentation, processes, and any other items which may adversely affect product quality.
· Overtime and alternate hours may be assigned in order to meet deadlines and provide support during heavy production periods.
· Performs work in a clean laboratory environment.
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