SUMMARY:
This position is responsible for assisting the QC Manager and QC department staff in general to meet the departmental expectations as identified below. The position will be supervising lab analyst, chemists, and microbiologist. Maintain the Stability Program. Oversight and hands-on testing shall include but not limited to Microbial, Chemical, physical, and research analysis. Objectives also include method development and method validation as instructed by management, as well as performing non-conformance investigations. Intermediate decision-making skills are required for this position. Examples of decision-making skills include prioritizing work, managing your time, and resolving daily challenges with the duties listed below.
DUTIES AND RESPONSIBILITIES:
* As needed Perform in- process, Finished goods, R&D and Stability API assay by HPLC or wet chemistry techniques.
* Oversee HPLC method validations, transfers, and verifications
* Provide day-to-day work assignments and prioritize workload for the laboratory staff.
* Coordinates Stability Program- writing protocols, setting pull schedule, pulling sample, maintaining results and summary reports.
* Serve as a back-up for making in-process batch adjustments by performing lab trails as instructed per the master batch record.
* Serve as a back-up microbiologist during vacations and PTO.
* Conduct OOS investigations.
* Write, review, approve Change controls, Deviations, Quality Investigations.
* Assure all associates are performing and documenting testing according to cGMP, SOP, and current industry practices.
* Assure all associates maintain a clean work area which includes cleaning glassware, counters, and equipment.
* Keeping the analytical laboratory supplies stocked and in order and notifying the manager when orders need to be placed.
* Training of new lab associates on revised SOP, Hands-on analytical techniques as well as continuous improvements.
* Assist with performance appraisals, coaching and or disciplinary action reports.
* Performs other related duties as assigned by management.
SUPERVISORY RESPONSIBILITIES:
Supervises employees within department.
* Responsibilities include interviewing, hiring, and training employees; planning, assigning, and directing work; appraising performance; rewarding and disciplining employees; addressing complaints and resolving problems.
QUALIFICATIONS:
* BS in Chemistry / Microbiology or related science field or equivalent hands-on experience.
* Read and write fluently in English
* Effective written and verbal communication skills in English
* Reason and analyze technical challenges, moderate decision-making skills
* Perform calculations as it relates to formulations, analytical lab work, and chemical concentrations.
* Ability to lead a small group by giving day to day instructions.
* Experience with HPLC integration software, microbial sampling, and testing techniques.
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