Training Leader QA Compliance

BaxterAibonito, PR
Onsite

About The Position

Provide training using the Job Instruction Breakdown procedures and specifications of the designed area to regular, temporary, part-time, contractor and transfer personnel. Assist supervisor in clerical duties.

Requirements

  • Knowledge in computerized systems.
  • Must be knowledgeable of GMP, Specifications and SOP's related.
  • Good communication and interpersonal skills.
  • Knowledge in English and Spanish.

Nice To Haves

  • Associate Degree in Administration, Education, Information System, Office Administration and Science.
  • At least 1-2 year of experience in Manufacturing and/or administration/clerical areas.

Responsibilities

  • Coordinates the training, certification, and re-certifications process of employees in his/her designated area.
  • Responsible in certifying area department instructor and process engineer at the start of a new process.
  • Responsible for data entry and monitoring of employees training records on to BAXU Training System.
  • Maintain file control of corresponding area employee manual certification records.
  • Maintain file control of each employee manual certification records and assure employees are certified in their designated areas as needed.
  • Review in conjunction with supervisor and process engineer the Training Manuals Procedure every two years.
  • Certifies employee’s assembly techniques by taking samples and inspecting them.
  • Maintains documentation controls of process.
  • Has active participation in plant working team.
  • Analyzes area complaints with supervisor.
  • Create, maintain and follow up Training Matrixes and Modules per position in BAXU.
  • Support safety chats.
  • Provide line support (TIQ, Group Leader) when necessary and assist in employee rotation in the different assembly techniques.
  • Support the annual GMP orientation to employees that do not attend initial training.
  • Reports to the Training Manager or Area Supervisor of the corresponding department for task assignments.
  • System verification of employees’ certification in “x” operation especially when the engineer validates equipment, assuring the protocol is run with certified personnel.
  • Verified with Process and Product Engineering Dept., changes in the manufacturing process or equipment validations.
  • Assure all personnel training and certification are updated if validations and modifications have been modified.
  • Manually document (ex: checker chart) and/or electronically (ex: POMs) the required information to comply with applicable procedures and specifications. This information includes, but is not limited to, process parameters, lots, amount of production, and others.
  • Ensure that the different areas comply with SOL6’S Program
  • Actively report health and safety hazards, environmental aspects, incidents, and EHS management system risks and opportunities.
  • Participate in the development, planning, implementation, performance evaluation and actions for continuous improvement of the EHS Management System.

Benefits

  • Medical and dental coverage that start on day one
  • Insurance coverage for basic life, accident, short-term and long-term disability, and business travel accident insurance
  • Employee Stock Purchase Plan (ESPP), with the ability to purchase company stock at a discount
  • 401(k) Retirement Savings Plan (RSP), with options for employee contributions and company matching
  • Flexible Spending Accounts
  • Educational assistance programs
  • Paid holidays
  • Paid time off ranging from 20 to 35 days based on length of service
  • Family and medical leaves of absence
  • Paid parental leave
  • Commuting benefits
  • Employee Discount Program
  • Employee Assistance Program (EAP)
  • Childcare benefits
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