Nesher Pharmaceuticals (USA) LLC
  • 25-Jun-2018 to 24-Aug-2018 (CST)
  • Quality Control
  • St. Louis, MO, USA
  • Full Time

Competitive Benefits Package


*Must be open to second shift

 

SUMMARY
Supervise the daily operation by overseeing testing and scheduling of work. Manage staff appropriately to meet cycle times. Find and eliminate inefficiencies and bottlenecks. Review and audit test results. Oversee the laboratory for GMP and safety compliance. Log in and receive samples as needed. Direct and coordinate OOS testing and data.

ESSENTIAL DUTIES AND RESPONSIBILITIES
Provide comprehensive formal and informal leadership to promote a positive work environment and communicate overall business expectations to QC.
Supervise chemists to include, but not limited to, oversee testing, check progress of samples for release, and ensure assigned tasks are performed.
Assign testing to chemists/microbiologists based on priorities.
Check test results for accuracy and proper documentation.
Generate status and backlog reports and distribute to appropriate personnel.
Write and update compendial and non-compendial methods for use by chemists for sample testing.
Interface with other departments for testing information required for methods and or proper documentation (testing procedures and requirements, certificate of analysis and/or specification sheets.).
Fulfill information requests from other departments (special testing, samples status, copies of test results and methods).
Provide methods and certificates of analysis to Regulatory Affairs for submission and method updates when requested.
Build and maintain a staff of professional, highly motivated and knowledgeable individuals. Participate in selection of personnel and provide for their effective and thorough training. Establish standards of performance in accordance with company guidelines and evaluate performance against those standards for all staff members, to include preparing and conducting performance evaluations.
Write OOS investigations, including finding root cause and corrective/preventive actions.
Meet timelines as required by the needs of the business.
Perform other related duties as assigned to meet departmental and Company objectives.

KNOWLEDGE/SKILLS/ABILITIES
Knowledge of regulatory guidelines such as cGMP.
Basic understanding of microbial testing.
Proficient in following and writing procedures such as SOPs and methods.
Proficient in a data acquisition system such as TotalChrom.
Proficient in a LIMS system.
Proven leadership qualities to mentor, coach, train and develop others.
Detail oriented with strong oral and written communication skills.
Mathematical ability and computer proficiency.
Problem-solving and deductive reasoning skills.
Proficient in writing and participating in OOS investigations.
Proficient in compendial guidelines such as USP and EP.
Ability to work independently with a diverse group of people in a fast paced, constantly changing environment, with little supervision.
Ability to interact with upper management and act as liaison between upper management and lab staff.
Ability to assume additional responsibilities on own initiative.

EDUCATION/EXPERIENCE
Bachelor's degree, preferably in Chemistry, Biology or other science discipline; or the equivalent in pertinent, progressive experience in pharmaceutical or other highly regulated industry.
Five years' experience in pharmaceutical or highly regulated industry.
Experience in a lead role or leading team projects desired.

WORK ENVIRONMENT
The physical demands described here are representative of those that must be met by an individual to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job the individual is required to:
1. Stand, walk, sit, reach, talk, and hear.
2. Have clarity of vision at 20 feet or more and 20 inches or less with the ability to judge distance and space relationships, bring object into sharp focus and see up and down or to the right or left while fixed on a point. Must also have the ability to identify and distinguish colors.
3. Exert an amount of force continuously and/or up to 5 pounds of force frequently and/or up to 25 pounds of force occasionally to lift, carry, push, pull, or otherwise move objects.

The work environment characteristics described here are representative of those an individual encounters while performing the essential functions of this job:
1. Normal office conditions.
2. Occasionally in a proximity to moving mechanical parts, laboratory equipment and exposure to chemicals.
3. Individual may be required to wear respiratory devices that include but are not limited to: Air Purifying Respirators (APR) which include half-face and full-face negative pressure respirators, hooded powered air purifying respirators, or Supplied Air Respirators (SAR), which include hooded or full face supplied air respirators.

Nesher Pharmaceuticals (USA) LLC
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