QC Trainer

Description:

• Demonstrates mastery knowledge of Aseptic techniques and microbial test methods.

• Evaluates job proficiency and skills while correcting and coaching workmanship and technique by completing analyst/engineer evaluations or proficiency assessments during microbiology activities including but not limited to environmental monitoring, plate incubations and enumerations, microbial identification, growth promotion, Gram staining, endotoxin, and sterility testing.

• Actively monitors analyst/engineering personnel’s technique and application of learning and provides feedback to trainees as well as to managers.

• Facilitates timely resolution and closeout of Corrective and Preventative actions specific to Training issues

• Partners with the Corporate Training Department to identify technical training needs and design, implement and deploy an effective and comprehensive training program while identifying improvements to the existing training curriculum.

• Establishes and/or revises technical educational training materials including but not limited to videos, guides, SOPs, LQMs, PMs, and Work Instructions. This training is not limited to aseptic technique, cell culture technique, environmental monitoring, laboratory assays, regulatory requirements such as GMP Documentation, cleanroom behavior, cGMP/ISO, and laboratory safety.

• Coordinates training related Operational Excellence (OE) initiatives.

• Participates in and/or contributes to advanced Business Process workflow activities (i.e., editing SOPs and training materials).

• Provides technical writing support for training related processes and procedures.

• Responsible for managing SOP revisions as well as continually improving the Microbiology training program.

Additional Skills & Qualifications:

Bachelors in related scientific field

Microbiology techniques

Gowning certification

• Bachelor’s Degree in Biology or related field with 3+ years of biopharma experience; Associates degree with 5-7 years of experience in biopharma environment; or relevant work experience in a cGMP environment.

• Experience in environmental monitoring, microbiological test methods, cell culture experience and/or Aseptic Technique in a cleanroom environment.

• Knowledge of aseptic techniques and skills, microbiology, contamination control, and clean room behavior

• Knowledge of biopharma laboratory and/or manufacturing experience.

• Knowledge of cGMP, GDP, GLP

• Computer software skills including Microsoft Office.

• 3+ years of experience in a training role preferred (particularly On-The-Job Training)

• Parenteral Drug Association (PDA) Aseptic Processing Training preferred