Training Specialist-FortaFlex

About Us

We have unique opportunities and are always looking for exceptional talent. Join a company where you will have an opportunity to grow professionally and personally and give strength to others by Empowering Healing. Our advanced wound care products are specially developed for the successful treatment of chronic and acute wounds. Our comprehensive portfolio of skin substitutes and other regenerative medicine products empower our patients with life-changing solutions. Our surgical & sports medicine products support the healing of musculoskeletal injuries and degenerative conditions. Our strength is giving others strength.

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What You Will Achieve:

Under the direction and supervision of the FortaFlex Manager, the FortaFlex Training Specialist I will support the FortaFlex manufacturing department by performing the tasks that will assure the safe and timely processing of the FortaFlex products. The Training Specialist I will also be responsible for training new employees, and maintaining training records of FortaFlex personnel. The associate will adhere to the appropriate SOP's, MBR's, and cGMP procedures in the general lab area as well as the Class 10,000 clean room.

How You Will Achieve It:

• Responsible for scheduling, performing, and documenting training of FortaFlex production team members.
• Responsible for maintaining personnel training records.
• Responsible for the initial and re-qualification of gowning for FortaFlex team members
• Participate in the development and revisions to the FortaFlex training program.
• Responsible for manufacturing FortaFlex products according to established Master Batch Records and Operating Procedures.
• Responsible for adherence to all Operating Procedures, protocols, policies, regulatory requirements, GMP, and safety guidelines.
• Responsible for assuring batch records are complete and are compliant with all protocols.
• Responsible for proper operation of all clean room equipment.
• Responsible for maintaining all required records and adherence to established guidelines for quality control procedures, GMPs, and safety.
• Provide assistance to Engineering and Facilities Departments, as necessary, for equipment operation during calibration, validation, or repair activities.
• Assist with New Products, Process optimization and scale-up activities, as necessary.

Requirements

What You Need to Achieve It:

• Required: High school diploma and 1-3 years' relevant experience. College-level Biology courses with laboratory experience will be considered a plus.
• Preferred: Biotechnology certificate or higher (AS, BS) in Biology and 1-3 years' relevant experience with GMP and clean room protocols.
• Knowledge and hands on experience with the Microsoft suite of products - Azure, Dynamics 365, Dataverse, Power Platform
• Excellent communication skills
• Demonstrated ability to follow Standard Operating Procedures and work within GMP guidelines.
• Demonstrated leadership ability.
• Ability to assess trainees' proficiency and provide feedback.
• Cleanroom protocol experience
• Manual dexterity, lifting 50 lbs, pushing/pulling ≤ 400 pounds (200 L)
• Ability to work in a cleanroom environment for extended periods of time.
• Heightened awareness and attention to detail
• Proficiency with Microsoft Excel and Word
• Ability to work with weights, balances, HLF hood, BSC hood, cleaning procedures, pH meters, heat sealers, clicker presses, and water bath.

What sets us apart?

• Competitive Pay
• 401K - vested immediately with 100% match
• Education Assistance Policy - $5,000 per year for all employees
• Medical, Dental and Vision
• Flexible Spending Account or Health Savings Account
• Wellness Program
• Three weeks of vacation, 4 floating holidays, sick days, and company holidays
• Discounts at BJs Wholesale, Dell, Sullivan Tire, and Sprint

We are an equal opportunity/affirmative action employer. All qualified applicants will receive consideration for employment without regard to age, sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected veteran status, or any other characteristic protected by law.