Operations Team Lead

summary

Perform functions related to the processing of drug products, consistent with established current Good Manufacturing Practices (cGMPs) and customer requirements, and in conjunction with all Standard Operating Procedures (SOPs). Assist with oversight of the production area to assure efficient execution of job duties while ensuring product compliance to established standards.

essential Duties and Responsibilities

• Clearly communicate supervisor's instructions and production schedules to employees in accomplishing a variety of tasks to meet safety, quality, accountability, security, and productivity requirements per SOPs, batch records and cGMPs.
• Report production progress as well as quality, security, accountability and efficiency discrepancies to supervisor.
• Perform equipment and room inspections.
• Assist, train and perform production duties as required in meeting production requirements.
• Promote teamwork and a positive work environment and encourage an atmosphere that enhances continuous improvement in efficiencies, positive material variances and product quality.
• Monitor training requirements and recommend training to supervisor to assure employees perform job tasks as designed.
• Establish consistent work instructions to production/packaging personnel in conjunction with supervisors' and managers' directions.
• Provide area oversight and assign tasks to production operators/technicians as directed.
• Assist with the revisions associated with batch records, SOPs and other documents as directed.
• Perform the audit and review of batch records and associated SAP transactions.
• Identify issues and work with supervisor to resolve them and assist with the related corrective actions.
• Recommend beneficial changes to those policies associated with the Operations function.
• Identify and participate in the implementation of continuous improvement initiatives/projects.
• Adhere to all cGMPs, compliance/regulatory mandates and quality requirements.
• Perform other related duties as assigned to meet departmental and Company objectives.
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KNOWLEDGE/SKILLS/ABILITIES

• Working knowledge of cGMP regulations and requirements, with ability to translate to operational details and communicate to work staff.
• Demonstrated understanding of the unit operations and the ability to assist with on-the-job training of manufacturing trainees.
• Strong interpersonal skills to coach and mentor personnel to achieve consistently high standards and to work effectively with diverse individuals.
• Excellent written and oral communication skills to deliver information and instructions in a respectful, clear, and concise manner.
• Demonstrated problem solving skills in identifying and resolving issues.
• Ability to execute tactical plans and maintain established timelines.
• Ability to develop and maintain strong working relationships with primary support functions.
• Ability to work and to solve problems independently with minimal supervision.
• Ability to work effectively in both independent and team environments.
• Able to operate and troubleshoot pharmaceutical processing equipment.

EDUCATION/EXPERIENCE

• High School Diploma or General Education Diploma (GED) required.
• Five years' pharmaceutical experience with increasing levels of responsibility in technical writing and training.

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, climb, balance, stoop or crouch, kneel, reach, push, pull, grasp, feel, talk, and hear.

1. 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.

1. Exert an amount of force continuously and/or up to 15 pounds of force frequently and/or up to 35 pounds of force occasionally and/or up to 75 pounds of force rarely by utilizing a hand truck 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. Sufficient noise to occasionally cause the individual to shout in order to be heard above the ambient noise level.

1. Individual is in a proximity to moving mechanical parts, electrical current and exposure to chemicals.
2. Atmospheric conditions sometimes expose individual to dust, for which protective equipment is available.
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.

Current Openings for Operations Team Lead Jobs at Nesher Pharmaceuticals (USA) LLC