Job Description

Agility, Impact, Methodology. Do you exhibit these values and wish to be around others that do too? Do you thrive in fast-paced environments where agility, adaptability, and high standards go hand in hand? Are you driven to make a meaningful impact, whether through your work, your support of others, or your commitment to your community? Are you motivated by a disciplined, science-based approach that ensures consistent excellence, safety, and integrity in everything you do? If these statements resonate with you, Grand River Aseptic Manufacturing (GRAM) welcomes you to apply to join our community of dedicated individuals improving lives every day!

Overview of this Position:

The training specialist supports GRAM’s training program which complies with Good Manufacturing Practices (GMP's), pharmaceutical quality standards, environmental, safety and external regulatory agency requirements. This includes assessing training needs, designing/developing, coordinating, and delivering training sessions for new and existing employees, as well as follow-up and evaluation to ensure training effectiveness.

Non-Negotiable Requirements:

• Bachelor's degree and/or a minimum of 4+ years of experience as a Training Specialist or Technical Trainer or a similar role within a pharmaceutical, biopharma and/or biotech. manufacturing environment.
• Knowledge of the full training life cycle including adult learning principles and instructional design theory.
• Knowledge of current Food and Drug Administration (FDA) laws, regulations, practices, and guidelines.
• Experience implementing, administering, and maintaining electronic quality systems.
• Experience with Articulate or similar eLearning software.
• Proficient Microsoft Office Applications (PowerPoint, Word, Excel, Outlook, Visio).
• Technical writing expertise, strong facilitation, organizational skills, knowledge of GMPs required.
• Must have proficient computer skills in Microsoft Word, Excel, and Outlook.

Preferred Requirements:

• Expertise in training programs for pharmaceutical industry is strongly preferred.
• Proficiency in use of Learning Management Systems (MasterControl preferred).
• Experience with instructional design for the development and delivery of effective classroom and computer- based training solutions.
• Prior experience working in a fast-paced, emerging growth CMO.

Responsibilities Include (but are not limited to):

• Manage and maintain users, course information, proficiency tests, and relevant documents in the Training Management System.
• Develop and revise training documents, materials & curricula in partnership with area management and site training department.
• Design and develop moderate to complex training eCourses by collaborating with SME’s.
• Deliver group and individual instruction and training covering a range of technical, operational, and/or management areas in a specified field by use of well-developed organizational, communication, and people skills.
• Collaborate with SME’s on Training documents (e.g. On the Job Training (OJT), Curricula) using standard work and best practices for formatting and processing.
• Formulate training outlines and determines instructional methods, utilizing knowledge of specified training needs and effectiveness of such methods as individual training, group instruction, lectures, demonstrations, conferences, meetings, and workshops.
• Support internal, client, and external regulatory inspections by providing documents from the MasterControl DMS, including offsite searching, electronic and physical retrieval from vendor.

Full job description available during formal interview process.

What Sets GRAM Apart from Other Employers:

MEDICAL BENEFITS starting day 1: Blue Cross Blue Shield medical and dental, vision, life insurance, and disability benefits are available to you and your family on your first day of work, with the company paying for 75% of the cost! Once eligible for the 401(k) program, all your contributions are immediately 100% vested, and you are immediately vested in GRAM contributions as well. We also offer generous off-shift premiums!

Paid VOLUNTEERISM starting day 1: GRAM encourages giving back to our community by offering 16 hours of paid volunteer time per calendar year!

PTO: Full-time employees accrue up to 13 days of time off per calendar year. You choose how to use this time for your vacation, sick, or mental health needs!

WELLNESS TIME OFF: Employees earn 1 hour of time off for every 30 hours worked to use how you choose.

PAID HOLIDAYS: We offer 10 paid holidays per calendar year with immediate eligibility!

PAY: Depends on Experience and is discussed during the interview process.

If you meet the required criteria listed above, GRAM welcomes you to apply today!