Quality Assurance Training Assistant

POSITION OVERVIEW

Role and Responsibilities

Belmar Select Outsourcing is an FDA registered 503B Outsourcing Facility with a location in Lakewood, CO and Golden, CO. We supply high quality hormone-replacement products to prescribers nationwide. We are rapidly growing our Quality Assurance Team. If you have an eye for detail, a positive attitude and enjoy a rapidly growing & fast-paced environment, this is the career for you!

This position reports to the Quality Assurance Training Manager. Depending on skills, experience, and desire to learn, the Quality Assurance Training Assistant will be placed in a specialty area with opportunities for growth and cross training. The Quality Assurance Training Assistant will perform a variety of activities serving multiple manufacturing facilities, including but not limited to the following:

Sun-Wed shift from 7:00am -5:30pm. This will include a 15% shift differential

RESPONSIBILITIES

Key Responsibilities:

• Certified Trainer training and support on the production floor.

• Daily check of Batch Production Records for correct training documentation.

• Assisting with the administration of personnel qualifications and requalifications for new hires and existing personnel.

• Preparing new hire training paperwork.

• Assisting with new-hire and existing employee module training.

• Ensuring personnel sign for training in ACE after training events such as classes, presentations, OJTs, proficiency observations, skills assessments, Group Trainings, etc.

• Assisting with one-on-one retraining when necessary for deviations, investigations, requalification failures, etc.

• Working with department supervisors and managers to schedule on-the-job training, performance assessments, qualifications, requalifications, etc.

• Digital uploads of all qualifications/requalifications into the Learning Management System.

• Filing training documents into training binders.

• Auditing of new hire training to ensure all required documentation has been completed.

• Tracking Belmar Select Outsourcing and Green Mountain Pharmaceuticals personnel qualifications and requalifications including vision screenings, annual GMP, and GDP training.

• Scheduling new hire and existing personnel vision screenings, etc. with approved vendors.

• Working with department supervisors and managers to build training schedules for new hires.

• Assisting with Group Training presentations and class training when needed.

• Writing or assisting with training deviations.

• Must be professional at all times.

• Performs other duties as assigned.

PHYSICAL REQUIREMENTS

• Onsite position (not remote)

• Ability to stand for long periods of time.

• Ability to bend, lift, push and pull.

• Required to wear personal protective equipment and work in a cleanroom environment for extended periods of time.

• Prolonged periods of sitting at a desk and working on a computer