What are the responsibilities and job description for the API Manufacturing Technician position at Benuvia?
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 :
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