Aseptic Compliance Program Lead
The mission of this role is to lead Aseptic compliance improvement in a critical, complex, high risk area of the business by developing and implementing long-term improvement plans that ensure organizational success. The Aseptic Compliance Program Lead will develop innovative ideas to create new and improve existing programs that drive compliant aseptic behaviors, practices and processes at Meridian now and into the future as well as ensure alignment with Pfizer Quality Standards (PQSs) and ever expanding regulatory expectations. This position must anticipate future aseptic requirements and proactively change the organization to meet those challenges.
The Aseptic Compliance Program Lead is a Subject Matter Expert in aseptic manufacturing, aseptic regulatory requirements, training, environmental monitoring, air flow visualization studies, change management and the development and implementation of programs designed to improve compliance in these areas. This role is part of the Meridian/ Brentwood SPM Support organization and is accountable for applying in-depth skills, knowledge, and abilities that drive continuous improvement to all aspects of the Aseptic Improvement Program (Aseptic Observation/Coaching, Aseptic Training, Aseptic Auditing) for Meridian; includes supporting existing program elements, designing, training, coaching of colleagues, auditing, maintenance and evolution to ensure the sustainability of the program. This position is a thought leader for aseptic manufacturing and compliance.
• Lead transformational changes to achieve aseptic best-in-class behaviors, practices and processes that is aseptically compliant now and in the future. Anticipate future requirements and correspondingly address challenges by updating and improving site strategy proactively.
• Serve as subject matter expert and technical lead for aseptic operations. Lead the aseptic program by evaluating, augmenting, improving and/or creating programs to improve aseptic manufacturing and regulatory compliance for the site now and into the future.
• Evaluate, develop, and implement innovative solutions to improve aseptic processes related to air flow visualization studies (smoke studies), validation media fill simulations, core aseptic manufacturing processes, auditing and training.
• Liaise with corporate compliance team to ensure alignment. Must interact with corporate personnel, cross-site colleagues, and industry experts to set the direction for the Aseptic Improvement Program to drive necessary change which may include influencing others.
EDUCATION: Bachelor’s Degree in Science (preferred degree in Microbiology, Biology, Biochemistry, Chemistry, Engineering, Pharmacy, or related science) and a minimum of 8+ years’ aseptic environment or supporting Aseptic Operation experience.
- Minimum experience in a cGMP environment, as described above, with in-depth knowledge of a variety of quality systems and processes as related to sterile manufacturing. The candidate must have demonstrated proficiency in organizational and project management skills and must be able to balance multiple priorities to meet established timelines. The candidate must have experience in at least several of the following: Aseptic manufacturing processes, environmental monitoring, inspection practices, cleaning and sanitization, cGLP/cGMPs, Regulatory (worldwide), deviation investigation, product and process validation, environmental testing and investigations.
- Communication: Excellent written and verbal communication skills with the ability to share vision, direction, and data with colleagues across all levels and in a wide range of different work groups including senior leadership and regulatory agencies.
- Success in Role: Effective leader. Action oriented. Strong analytical and problem-solving abilities. Tactful, persuasive and assertive human relations skills. Capable of making decisions using experience along with site process and procedures. Robust interpersonal skills and the ability to handle multiple projects.
- Role is self-directed and requires an appropriate level of education, experience and confidence to make and act upon decisions that impact the site.
- 2+ years supervisory experience in an aseptic manufacturing environment preferred.
- Training experience is desired.
- Job will include standing, walking, sitting, ability to perform mathematical calculations and complex data analysis.
- The capability to aseptically gown.
- The capability to focus attention on the colleagues’ behaviors that in turn leads to higher than normal performance.
- Ability to hold self and others accountable and to encourage colleagues to take personal responsibility for their performance / actions.
- Demonstrated ability of strong self-awareness
- Knowledge of pharmaceutical manufacturing and regulatory compliance.
- Ability to coach combined with a willingness to develop others and to share ideas.
- Demonstrated aptitude to execute Aseptic techniques to a high degree of proficiency.
- Expert at providing constructive feedback that leads to positive reinforcement.
- Must be able to communicate and work well interdepartmentally, as well as, with all plant departments.
- Must be able to read and write, as well as, follow written and oral instructions.
- Must be capable of performing data entry into calculators and computers.
- Must be self-motivated, able to work independently and have a problem-solving mindset.
- Promote a positive team environment.
- Perform all tasks in a safe manner.
- Job duties involve occasional lifting (less than 35 lbs.), reaching, and sitting while working at computer terminal.
- Successful candidate will be required to complete various levels of gowning certification in order to enter and support the manufacturing areas.
NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS
This is a 1st Shift Position with support to 2nd and 3rd shift production. Job may require occasional weekend/evening work supporting a 24-hour/7-day operation.
The job is open only to Protected Individuals (as defined by 8 U.S.C. § 1324b(a)(3), namely, Citizens or Nationals of the United States, Lawful Permanent Residents (“green card holders”), Refugees and Asylees.
Last date to apply for job: October 31, 2021
Eligible for Employee Referral Program
Eligible for Relocation Support
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