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Associate Director of Quality Training

Company: QUVA PHARMA
Location: Bloomsbury
Posted on: April 6, 2021

Job Description:

Establishes the cGMP Training Program for the QuVa Bloomsbury site. The position will coordinate with Human Resources in structuring the training program to coincide with employee development. Develops and manages the programs for training Operations and Quality colleagues on clean room aseptic techniques related to compounding operations. Maintains annual qualification plans, according to Aseptic Process Simulation program. Facilitate the implementation of the Training Program in accordance with QuVa Pharmas QMS requirements. Establish the cGMP training program for new employee orientation, including individual training plans. The training program will track the progress of individual training plans, assure subject manner expert are certified trainers and are available to support on the job training. The program will assure required training documentation is obtained, propose effective methods of training, and perform verification and effectiveness checks in conjunction with completion of individual training plans. The position will coordinate with the Quality Investigation Team to identify opportunities for training improvements and implement enhancement to training plans and processes. The position will provide the Production Planner a tracking of qualified employees for specific job functions in support of setting the manufacturing schedule. Coordinate with other QuVa sites to develop Quality Standards for training to establish a standardization for training at a corporate and site level. Responsibilities may include:

  • Manages program for verification of training for aseptic gown practices / qualification
  • Establishes and maintains program for training on appropriate aseptic techniques and practice in clean room environments
  • Establishes and maintains program for training for the cleaning of the clean room areas according to procedure
  • Establishes and maintains program for initial and ongoing training of new employees with completion of required documentation
  • Tracks requirements for Aseptic Process Simulation Program with respect to training
  • Ensures advanced complex media fill verifications are performed on employees as required
  • Establish program to coordinate individual training schedule in conjunction with production workflow and requirements assuring training materials, subject manner experts and required documentation is in place
  • Prepare training plans for individuals based on position titles
  • Assure on-the-job skills training is formalized using checklist and observation
  • Monitor individual training against approved training plan and escalate any delays or concerns with department management. Trend outputs in support of continuous improvement
  • Verify and measure the effectiveness of the training methodologies and materials used to support individual plans and on-the-job training activities
  • Establish an effective train the trainer program
  • Actively observe and provide feedback to both trainers and trainees to continuously improve the effectiveness of the training process
  • Escalate issues or concerns associated with training process to site leadership team
  • Facilitate communications and discussion between trainees and trainers, area management and the site leadership team regarding the status, opportunities for improvement and resources required to assure training objectives are achieved
  • Integrate training program with site Production Scheduler in support of the manufacturing schedule
  • Integrate training program with QIT in order to enhance employee training to prevent recurrence of deviations
  • Standardize training program with other QuVa sites Qualifications:
    • Legally authorized to work in the job posting country
    • Bachelors Degree in Life Science or other related field
    • Minimum 10 years prior experience in Quality Assurance / cGMP / FDA regulated industry
    • Minimum 5 years of supervisory or management experience required
    • Training in aseptic processes for manufacturing of sterile injectable pharmaceuticals is preferred
    • Proficient with MS Office software (Word & Excel)
    • Excellent technical writing and verbal/written communication skills
    • Must have proven interpersonal skills, and be able to supervise the activities of subordinates
    • May require local travel by car to other QuVa Pharma locations To be considered: In order to be considered for this position you must complete the entire application process, which includes answering all prescreening questions and providing your eSignature on or before the requisition closing date. Candidates for regular U.S. positions must be a U.S. citizen or national, or an alien admitted as permanent resident, refugee, asylee or temporary resident under 8 U.S.C. 1160(a) or 1255(a)(1). Individuals with temporary visas such as E, F-1, H-1, H-2, L, B, J, or TN or who need sponsorship for work authorization now or in the future, are not eligible for hire. It is the policy of QuVa Pharma to afford equal opportunity for employment to all individuals regardless of race, color, age, national origin, physical or mental disability, history of disability, ancestry, citizenship status, political affiliation, religion, gender, transgender, gender identity, marital status, status as a parent, sexual orientation, veteran status, genetic information or other factors prohibited by law, and to prohibit harassment or retaliation based on any of these factors.

Keywords: QUVA PHARMA, Bethlehem , Associate Director of Quality Training, Executive , Bloomsbury, Pennsylvania

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