Production Associate III-Solutions Prep

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.

Careers at Organogenesis:

What You Will Achieve:
The Production Associate III is required to prepare all sterile and non-sterile solutions according to established procedures in an ISO 7 clean room. In addition, they will also assist with ensuring that all team members are aware of tasks and completing them in a timely fashion. The Associate III will assist with training, or coordinating training, of all Solution Prep team members.

The Associate III will also assist in setting up and maintaining training files of all team members. In addition, the Associate III will assist with biennial updates for documents, complete equipment tasks covered in RAM (Blue Mountain Asset Manager) and will work closely with the Supervisor and/or Manager.

How You Will Achieve It:

• Responsible for preparing all solutions according to established Master Batch Records and Operating Procedures.
• Measuring chemicals
• Mixing
• pH/osmolality assessment
• Aseptic Dispensing
• Line Clearance
• Responsible for assuring all batch records are complete and are compliant with all protocols.
• Assisting in coordinating training of new personnel.
• Assist with technical training and updating Solution Prep associates.
• Assist with scheduling, performing (when applicable), and documenting training of Solution Prep associates.
• Assist with maintaining personnel training records
• Assist with aseptic requalification and assisting in performing annual re-certification (if applicable) of team members
• Participate in the execution of the Aseptic Process Simulation Re-Validation on a semi-annual basis.
• Assist in Maintaining the ISO 7 laboratory area
• Ensuring cleaning of Equipment
• Maintenance of Monthly Equipment Logs
• Maintain FIFO of Glassware, Chemicals, and Autoclaved materials
• Adherence to all Operating Procedures, Protocols, Policies, Regulatory Requirements, GMP, and Safety Guidelines
• Participate in ordering Supplies for Solution Prep Area
• Participate in Hazardous Waste disposal
• Participate in Writing and Revising manufacturing documents and procedures and ensuring compliance with biennial review requirements.
• Assist with maintaining all records and adherence to established guidelines for Quality Control procedures, cGMP, and Safety
• Assist in deviation investigations and CAPAs, as needed.

What You Need to Achieve It:

• B.S. or A.S. in Biological Science or equivalent, with 3-5 years of relevant experience.
• Aseptic skills are highly desirable.
• Experience in Solution Preparation or GMP manufacturing (3+ years experience) is desirable.
• Proficiency with computers preferred (MS Excel, MS Word, ERP system). Quality Systems regulations (cGMP) knowledge and clean room experience desired.
• Production and Processing
• Ability to work in a clean room environment
• Work as a member of a team as well as independently
• Problem solving skills
• Manual dexterity
• Heightened awareness and attention to detail
• Ability to lift and move objects in excess of 25 lb
• Scientific and Technical Knowledge
• Consistently demonstrates proficiency in the application and use of new and existing technologies
• Assist in training of scientific and technical principles, techniques and procedures
• Communication skills
• Writing skills
• Basic computer skills with a working knowledge of Microsoft Word and Excel
• Proven organizational and documentation skills
• Knowledge of an Electronic Documentation system, example:
  Smart Solve
• Taking initiative
• Proven leadership ability

What can we offer you?

• 401k -- generous employer match with immediate vesting and financial planning resources
• Comprehensive Medical, Dental and Vision coverage…