Production assembler

Production Assembler Job Description

POSITION SUMMARY

This position is responsible for performing operations related to the handling and / or packaging of drug products through packaging operations, clean-up and maintenance in compliance with all regulatory requirements, company policies and procedures.

ESSENTIAL AREAS OF RESPONSIBILITY

Areas of responsibility listed below are essential to the satisfactory performance of this position :

• Responsible for learning the manufacturing and / or packaging process as assigned by following approved batch records (BR), work instructions (WI), standard operating procedures (SOP), etc.
• Responsible for following SOP's and Work Instructions in the handling and packaging of human drug products.
• Ability to read and understand SOP's and Work Instructions and follow direction from Supervisor.
• Responsible for keeping a clean and organized work area as required by SOP's and WI's.
• Responsible for completing documentation as required in the handling and / or packaging of drug product.
• Responsible for completing all training requirements and maintaining 100% compliance with all 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 working at a fast pace and meeting KPI as dictated by Supervisor. (KPI different based on job at hand)
• Responsible to bring any quality issues immediately to Supervisor upon discovery.
• Responsible for performing additional related duties as assigned.

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.
• Prefer previous experience in a manufacturing environment within pharmaceutical, nutraceutical or food processing industries.

Skills / Knowledge / Abilities :

• Basic computer skills with working knowledge of MS Office products may be required (additional experience with systems such as WMS, ERP, etc. preferred).
• Ability to receive instruction and follow directions in English.
• Ability to interact positively with co-workers and management.
• Ability to communicate effectively with written and oral communication skills in English.
• Ability to follow company policies and procedures.
• Ability to follow cGMP and other regulatory requirements.
• Ability to operate and troubleshoot production equipment when trained to do so.
• Detail oriented with ability to identify errors and / or inconsistencies while performing tasks.

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 SOP's and policies and selects methods and techniques for suggesting and obtaining solutions.
• May be asked to recommend methods and procedures for problem resolution by Supervisor.

PHYSICAL REQUIREMENTS :

Constant :

• Standing for extended periods of time at work station or equipment.
• Walking to move short distances quickly and frequently.
• Using fingers to perform activities such as picking, pinching, placing labels or typing.

Frequent :

• Stooping, Kneeling and / or Crouching bending body, spine and / or legs.
• Twisting / Reaching turning at waist and extending hands and / or arms in any direction.

Occasional :

• Sitting for periods of time at work station or equipment.
• Climbing use of feet, legs, hands and / or arms to ascend or descend.
• Pushing and / or Pulling using upper extremities to exert force.
• Grasping applying pressure to an object with the fingers and palm.
• Repetitive Motions - frequent motions of the wrists, hands and / or fingers.
• Lifting raising from lower to upper and / or moving objects horizontally up to 25 lbs., up to 70 lbs.

Visual Acuity :

• Perform activities such as inspecting bottles and labels where the seeing job is at or within arm's reach.
• Perform activities such as 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.

Work Attire and Guidelines :

• Due to COVID-19 all associates are required to wear facial masks while in our facility and follow all Social Distancing guidelines as recommended by the CDC and our company.
• Business casual attire is recommended.
• Associates may wear jeans of good repair (no tears, frays or holes).
• Socially acceptable T-Shirts can be worn (No abusive or offensive pictures or slogans). Associates will be asked to change or leave if they come to work wearing these.
• Closed toe shoes must be worn tennis sneakers are allowed and must be in good repair, no holes or excessive dirt or grime.
• Shorts are NOT allowed.
• Undergarments must be covered and not visible.
• NO CELL PHONES are allowed on production lines or in production areas.
• Associates cannot bring food, drinks, purses or bags onto the production floor, they must be kept in lockers or fridge (provided).
• Associates can bring a lock to lock their personal good into lockers.
• Refrigerators are available to store lunches and food. Please mark food / lunches with names to avoid confusion.
• Coffee and soft drinks are provided free in the breakroom. Please do not abuse this privilege.
• Associates are not to wander throughout the building or office areas and will be assigned an entry and exit point for the facility.

They are to only stay in their assigned work areas, the breakroom and the bathrooms near the breakroom. Violators will be asked to leave immediately.

Failure to comply with any of the above listed requirements or rules will result in disciplinary action up to and including immediate dismissal.

Alliant Pharmaceutical Services, LLC is an Equal Opportunity / Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, protected veteran status, sexual orientation, or gender identity.

Last updated : 2024-09-30