Job Details

API Manufacturing Technician is required to work in a cGMP, bulk chemical, manufacturing facility with responsibilities related to the production of Active Pharmaceutical Ingredients (API).

Reports to the API Manufacturing Supervisor and will also have interactions with other departments including Quality Control, Quality Assurance, Material Management and R&D.

DUTIES AND RESPONSIBILITIES

• Maintain production duties as scheduled by shift lead or supervisor
• Keep current on all required training and SOPs
• Assist in maintaining a clean laboratory
• Adhere to safety protocols and policies
• Operate equipment following SOP guidelines and protocols
• Ensure cGMP documentation is followed
• Review batch records and related documentation for accuracy
• Perform Operational Qualifications and Installation Qualifications with guidance from experienced members of the API group on GMP equipment as necessary
• Notifies experienced members of equipment malfunctions to minimize disruption to production schedules
• Report all issues and concerns to shift lead or supervisor
• Manage appropriate tasks designated by shift lead or supervisor

QUALIFICATIONS

• Must be detail oriented, self-motivated, have the ability to multi-task in a production environment and assist in planning daily activities to achieve short term and long-term objectives in a quality environment.
• Must be able to follow written procedures and protocols relevant to assigned tasks.
• Must be flexible with schedule as production timelines dictate and ability to work minimal overtime.
• Minimum of an associate's degree or equivalent in the related field with emphasis and experience in Organic Chemistry and entry level position; or 1-2 years of work experience in a chemistry lab setting, preferred large knowledge of general laboratory skills.
• Understanding of High-Pressure Liquid Chromatography in cGMP operations preferred.
• Effective written and verbal English communication skills required.
• Drug Screen and DEA Background check required.

WORKING CONDITIONS/ PHYSICAL REQUIREMENTS

• Must have no physical limitations that would prevent:
• Being able to periodically lift 50 pounds or more
• Being able to climb a ladder
• Being able to wear a full-face respirator
• During certain operations, the worker will be required to wear a full-face respirator and other PPE while performing physically strenuous activities for extended periods of time.
• Will have annual occupational medical assessment to ensure “fit for duty.”
• Required to work in an environment with chemical, fall, drop, and trip hazards.
• Required to handle controlled substances.
• Required to work with electrical hazards.
• Required to handle and work in the presence of large amounts of several hazardous materials, including those that are:
• Flammable / explosive
• Carcinogenic
• Oxidizing agents
• Respiratory hazards
• Highly acidic / basic
• Under high pressure
• At high temperature
• Halogenated solvents
• Organic materials