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SalaryPosition Summary:
To perform this job successfully, an individual must be able to perform each essential function satisfactorily. The requirements listed above are representative of the knowledge, skill, and/or ability required. Reasonable accommodation may be made to enable qualified individuals with disabilities to perform the essential functions.
While performing the responsibilities of the job, the employee is required to talk and hear. The employee is often required to remain in a stationary position for a significant amount of the work day and frequently use their hands and fingers to handle or feel in order to access, input, and retrieve information from the computer and other office productivity devices. The employee is regularly required to move about the office and around the corporate campus. The employee is regularly required to stand, walk, reach with arms and hands, climb or balance, and to stoop, kneel, crouch or crawl. Employee will regularly be exposed to areas in which moving mechanical parts, fumes, toxic chemicals are present. The noise level for this position will vary and the employee may be exposed to loud noise levels. Employee may occasionally be required to lift up to 25 lbs. Vision abilities required by this job include close vision. Knowledge and Skills:
Key Competencies
Additional Voluntary Benefits
The Manufacturing Training Specialist is responsible for developing and implementing training programs and processes that equip manufacturing personnel with the knowledge and skills required to meet the rigorous standards of sterile drug production under 503B regulations.
Duties and Responsibilities: - Designs, develops, and implements comprehensive training programs that align with 503B sterile manufacturing regulations and guidelines.
- Designs training materials, programs, modules, and assessments to ensure cohesive understanding and competence among manufacturing staff.
- Regularly updates training content to reflect the latest industry standards and regulatory changes.
- Provides training on Good Manufacturing Practices (cGMP) and Good Documentation Practices (GDP) to ensure compliance with regulatory requirements.
- Oversees gowning qualification processes, including training and evaluation, to maintain aseptic gowning standards.
- Develops and executes training modules related to media qualification, ensuring technicians can perform these tasks accurately and efficiently.
- Maintains accurate and up-to-date training records, including documentation of training completion and certifications.
- Collaborates with Quality departments and Manufacturing management to ensure training materials support compliance efforts.
- Conducts hands-on training sessions for manufacturing personnel, including aseptic techniques, cleanroom procedures, and equipment operation.
- Supervises, facilitates, and assesses trainees in controlled sterile manufacturing environments and or simulated areas to ensure proficiency and safety.
- Develops and implements methods to assess the competency and effectiveness of training programs.
- Monitors and evaluates employee performance to identify areas for improvement and additional training needs.
- Stays updated on industry trends, best practices, and regulatory changes related to sterile manufacturing.
- Collaborates with cross-functional teams to implement process improvements and enhance training programs accordingly.
- Promotes a culture of safety, quality, and compliance within the manufacturing team.
- Collaborates on root cause analysis and provides training-based solutions to prevent errors and deviations in manufacturing processes.
- Maintains clear communication with manufacturing staff, trainers, and management regarding training initiatives and progress.
- Monitors and analyzes KPIs related to training, including training effectiveness, compliance, and technician performance, and provide regular reports to leadership.
- Performs other duties as assigned.
To perform this job successfully, an individual must be able to perform each essential function satisfactorily. The requirements listed above are representative of the knowledge, skill, and/or ability required. Reasonable accommodation may be made to enable qualified individuals with disabilities to perform the essential functions.
While performing the responsibilities of the job, the employee is required to talk and hear. The employee is often required to remain in a stationary position for a significant amount of the work day and frequently use their hands and fingers to handle or feel in order to access, input, and retrieve information from the computer and other office productivity devices. The employee is regularly required to move about the office and around the corporate campus. The employee is regularly required to stand, walk, reach with arms and hands, climb or balance, and to stoop, kneel, crouch or crawl. Employee will regularly be exposed to areas in which moving mechanical parts, fumes, toxic chemicals are present. The noise level for this position will vary and the employee may be exposed to loud noise levels. Employee may occasionally be required to lift up to 25 lbs. Vision abilities required by this job include close vision.
- Strong understanding of 503B sterile manufacturing regulations and FDA cGMP guidelines.
- Detail-oriented with the ability to maintain accurate records and documentation.
- Strong problem-solving skills and the ability to adapt to changing regulatory environments.
- Communicates effectively, both verbally and written, with personnel at all levels in a professional manner.
- Proficient in Microsoft Office Skills-Excel, Word, PowerPoint, Outlook.
- Knowledge of Learning Management Systems (LMS) and training software.
Key Competencies
- Customer Focus: Ability to build strong customer relationships and deliver customer centric solutions.
- Optimizes Work Processes: Know the most effective and efficient processes to get things done, with a focus on continuous improvement.
- Collaborates: Builds partnerships and works collaboratively with others to meet shared objectives.
- Resourcefulness: Secures and deploys resources effectively and efficiently.
- Manages Complexity: Makes sense of complex, high quality, and sometimes contradictory information to effectively solve problems.
- Ensures Accountability: Holds self and others accountable to meet commitments and objectives.
- Situational Adaptability: Adapts approach and demeanor in real time to match shifting demands of different situations.
- Communicates Effectively: Develops and delivers multi-mode communications that convey a clear understanding of the unique needs of different audiences.
- Bachelor's degree in a relevant field (Pharmaceuticals, Life Sciences, or Education). Advanced degrees or certifications in Pharmaceutical Sciences or Training & Development are a plus.
- 3-5 years prior experience in pharmaceutical manufacturing and sterile compounding, with a focus on aseptic techniques and cleanroom operations.
- Proven experience in designing and delivering effective training programs in a pharmaceutical manufacturing environment.
- No-Cost Medication: Get your prescribed compounded medications at no cost, ensuring your health without the financial burden.
- Onsite Health & Wellness – IV Therapy Drips: Rejuvenate with complimentary onsite IV Therapy drips, enhancing your well-being and energy levels.
- Comprehensive Medical, Dental, and Vision Options: Choose from three medical plans tailored to your needs, plus options for dental and vision coverage for you and your family.
- Telehealth visits: Access board-certified Doctors anytime, anywhere for you and your family.
- Paid & Volunteer Time Off: Enjoy paid time off for personal pursuits and contribute to causes you care about with volunteer time off.
- Paid Holidays (8 scheduled; 2 floating): Celebrate with eight scheduled holidays and two floating holidays, giving you flexibility and time for personal traditions.
- Life & AD&D Coverage: Secure your and your family's financial future with life and accidental death and dismemberment (AD&D) insurance.
- FSA (Flexible Spending Account): Manage healthcare expenses smartly with pre-tax dollars in a Flexible Spending Account (FSA).
- 401K Dollar-for-Dollar Up to 4%: Invest in your future with our 401K plan, featuring a dollar-for-dollar match up to 4%.
- Company Paid Long-Term Disability: Provided at no cost, which replaces 60% of your income if you become disabled for a long period of time.
- Flexible Schedules: Balance work and life seamlessly with our flexible scheduling options.
- Rewards & Recognition Program: Your hard work doesn't go unnoticed – enjoy rewards and recognition beyond your paycheck.
Additional Voluntary Benefits
- Accident Insurance: Pays a lump sum benefit to help cover expenses following an accidental injury.
- Hospital Indemnity Insurance: Enhance your peace of mind with supplemental hospital insurance for unexpected stays.
- Critical Illness: Protect your finances from the expenses of a serious health issue.
- Short-Term Disability: Protect your income during illness or injury with short-term disability coverage.
- Supplemental Life & AD&D: Add an extra layer of financial protection for you and your loved ones with supplemental life and AD&D coverage.
- Legal Services: Access professional legal assistance to address concerns confidently.
- Identity Theft Protection: Safeguard your identity and finances with our identity theft protection benefit.
- Pet Insurance: Care for your furry family members with our pet insurance coverage.
- Employee Assistance Program: Confidential counseling and support services for a holistic approach to your well-being.
