The opportunity
POSITION SUMMARY
Under close supervision, responsible for operating complex equipment, maintaining accurate documentation and completing basic set-up of equipment.
ESSENTIAL AREAS OF RESPONSIBILITY
All areas of responsibility listed below are essential to the satisfactory performance of this position by any incumbents with reasonable accommodation if necessary. Any non-essential functions are assumed to be included in other related duties or assignments.
Responsible for maintaining work areas and performing job functions in a safe and efficient manner in accordance with company policies and procedures, Good Manufacturing Practices (cGMP’s), Standard Operating Procedures (SOP’s) and Batch Record instructions.
Responsible for completing all training requirements and maintaining 100% compliance with all assignments.
Reports process or equipment problems to supervisor; performs minor or basic troubleshooting.
Ensures batch records, equipment log books, and other relevant records are current; performs batch record reconciliation.
Maintains records of manufacturing process by recording data on batch record.
Sets-up and operates equipment for processing operations.
Communicates effectively with previous and incoming shift operator and related personnel.
Cleans and maintains processing rooms and equipment.
Monitors process and equipment and makes necessary adjustments to maintain batch record specifications.
Monitors product quality.
Performs reconciliations.
Conducts in-process testing.
Checks and adjusts calculations.
Checks/reviews labels and batch records for accuracy.
Understands concept of delivery/on-time production.
Follows established department SOP’s and batch record instructions.
Complies with all Company policies and procedures, including safety rules and regulations.
Responsible for performing additional related duties as assigned.
Your experience and qualifications
POSITION REQUIREMENTS
Any equivalent combination of education, training and/or experience that fulfills the requirements of the position will be considered.
Education/Certification/Experience:
Requires High School Diploma or equivalent with a minimum of 0-1 year relevant progressive manufacturing experience, preferably in the pharmaceutical industry.
Skills/Knowledge/Abilities:
Current Good Manufacturing Practices (cGMP), Food and Drug Administration (FDA), and other regulatory requirements.
Proper English grammar and punctuation.
Effective oral and written communication skills.
Basic math skills.
Working independently as well as in a team environment.
SOP’s, cGMP’s, equipment and safety practices.
GMP compliance in a regulated work environment.
Manufacturing processes and equipment procedures.
Record keeping skills.
Providing excellent customers service with both internal and external customers.
Ability to use material handling equipment.
Complying with all Company safety rules and regulations.
Problem Solving:
Works on assignments that are routine to semi-routine in nature where the ability to recognize deviation from accepted practice is required.
Exercises judgment within specifically defined practices and policies and selects methods and techniques for obtaining solutions.
Normally receives general instruction on routine work and detailed instruction on new assignments.
May be asked to recommend methods and procedures for problem resolution.
PHYSICAL REQUIREMENTS:
Frequent:
Standing for extended periods of time at work station or equipment
Stooping, Kneeling and/or Crouching – bending body, spine and/or legs (for non-office)
Twisting/Reaching – turning at waist and extending hands and/or arms in any direction
Pushing and/or Pulling – using upper extremities to exert force
Repetitive Motions (frequent motions of the wrists, hands and/or fingers)
Lifting – raising from lower to upper and/or moving objects horizontally, up to 50 lbs.
Occasional:
Sitting for extended periods of time at work station or mobile equipment
Walking to move short distances quickly and frequently
Visual Acuity:
Close visual acuity to perform activities such as computer work, preparing and analyzing data, extensive reading, visual inspection involving small defects, small parts and/or operation of machines (including inspection), using measurement devices and/or assembly or fabrication of parts at a distance close to the eyes. Visual acuity to perform activities such as operating machines (i.e. lathes and drill presses) where the seeing job is at or within arm’s reach.
WORKING ENVIRONMENT:
Exposure to moving mechanical parts or moving equipment
Exposure to low to loud noise levels
Exposure to fumes, odors, dusts, mists or gasses (for non-office)
