Training Manager - Monroe, North Carolina United States - 20104

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JOB DESCRIPTION

Job #: 20104
Title: Training Manager
Job Location: Monroe, North Carolina - United States
Employment Type:
Salary: $75,000.00 - $95,000.00 - US Dollars - Yearly
Employer Will Recruit From: Nationwide
Relocation Paid?: Negotiable

WHY IS THIS A GREAT OPPORTUNITY?


We are actively seeking a Training Manager to join our growing team. Under the direction of the Senior Manager, Quality Systems and Compliance, the Training Manager is responsible for leading a team of Training Specialists and overseeing all aspects of the development, implementation and maintenance of the GxP training program for the site including, but not limited to, training related to Standard Operating Procedures (SOPs), On the Job Training (OJT), classroom-based training and 3rd party training for the entire site. The Training Manager is also responsible for partnering with Area Management to drive the Quality culture and mindset at the site.

JOB DESCRIPTION

Responsibilities include but are not limited to: 

  • Be cost effective and vigilant of laboratory reagents, glassware, etcetera to ensure department is within the Revenue and Capex Budget as per spent analysis project.
  • Provide leadership, mentoring and development opportunities for the Training staff.
  • Ensure Training staff are appropriately trained and aligned to support plant operations.
  • Provide Strategic direction to the Training group in alignment with site and QA objectives, to ensure that business and compliance needs are met.
  • Ensure the Training staff is available and active in first response to training-related quality issues for all shifts.
  • Monitor all Training-related activities throughout the facility.
  • Manage the development and administration of all training processes and systems in a manner compliant with Current Good Manufacturing Practices (CGMP), site procedures and any other applicable regulatory requirements.
  • Control and maintain inventory over the storage and movement of personnel training records stored in the Document Control Cell (hardcopy records) and within the electronic Quality Management System in compliance with regulatory requirements and internal record retention policies.
  • Perform trending to ensure shifts in normal operating conditions are detected and corrected.
  • Write, review and revise as needed applicable Standard Operating Procedures (SOPs) governing Training program.
  • Maintain Annual Training Calendar for the site and ensure compliance.
  • Ensure critical procedures have appropriate mechanisms to demonstrate comprehension and understanding.
  • Liaise across all levels and departments in the business to partner, educate and support internal customers in the setup and administration of overall site, departmental and job-function based curriculum, management of training for consultants/contractors/vendors, and compliance to   assigned requirements.
  • Partner with Document Control and other functional departments to   coordinate training on new or revised procedures.
  • Administer required training for the site, including, but not limited to, Train the Trainer, Current Good Manufacturing Practices, Good Documentation Practices.
  • Support all internal and external or regulatory inspections and audits.
  • Ensure all training documents and personnel qualifications are easily retrievable and accurate.
  • Coordinate, schedule and manage any third-party training for employees.
  • Other duties as assigned.
  • Manage the   implementation and upkeep of a 21 CFR Part 11-compliant learning management   system.
  • Establish Key Performance Indicators (KPIs) for functional area and ensure systems are operating within target.

QUALIFICATIONS

Education: 

  • A minimum of a Bachelor’s degree in Science or Engineering or associated fields is required. Advanced degrees may be used to reduce required experience. 

 

Experience: 

  • Minimum of 8 years of Quality Assurance experience in the Pharmaceutical, Biotech or medical device industry (or related industry).
  • Demonstrated managerial experience in Training and/or Quality Assurance.

 

Knowledge & Skills: 

  • Must be proactive, results oriented, with a strong attention to detail.
  • Ability to breakdown and convey complex material in simplistic terms using a variety of instructional techniques or formats for educating and training staff at all job levels in the organization.
  • Strong understanding of Good Manufacturing Practices (GMP), Good Laboratory Practices (GLP) and Good Documentation Practices (GDP).
  • Must be proactive, results oriented, with a strong attention to detail.
  • Self-starter with good work ethic and ability to work independently with minimum supervision and good judgment, or as contributing member of team.
  • Strong organizational, analytical, troubleshooting and problem-solving skills. 
  • Ability to analyse details and perform structured decision-making on daily basis.
  • Must be able to read, write, and speak English.
  • Excellent verbal and written communication/documentation skills. 
  • Strong interpersonal skills with ability to interact with all levels of personnel in a professional manner.
  • Good computer skills with basic knowledge of Microsoft programs, particularly Outlook, Word, Excel, etc. 
  • Knowledge of LIMS (Laboratory Information Management System), SAP™ (Systems, Applications & Products in Data Processing) and/or other electronic Quality Management Systems is a plus.
  • Prior experience with MasterControl™ desirable.

 

Leadership Attributes: 

  • Support the Management to organize and maintain the QC team, good communications skills, front runner, and GMP trainer.

Education:
University - Bachelor's Degree/3-4 Year Degree