Weighing and Blending Operator - 1st or 2nd Shift

Department

Manufacturing

Job Title

Weighing & Blending Operator

FLSA Status

Non-Exempt

Reports To

Manufacturing Supervisor

1. Role Purpose:

Responsible for performing tasks to specifications related to oral solid and liquid dose pharmaceutical manufacturing. Processes include weighing of raw materials, excipients and blending of these materials.

2. Key Duties & Responsibilities:

Primary Responsibilities:

• Ensure the proper set-up and operation of standard pharmaceutical process equipment such as, Sifters, Blenders, and ancillary equipment (Ex. weighing scales, sampling thief’s)
• Perform all in-process testing, sampling and inspections as required by the Master Batch Record (i.e. sampling, loss of drying, etc.)
• Dispensing, weighing and verifying raw materials (actives and excipients) as per Manufacturing Batch Record
• Operate blending, and sifting equipment in Dispensing/Blending Room and as per BMR instructions
• Clean and sanitize equipment and manufacturing rooms including walls, floors, and ceilings per current SOPs.
• Ensure proper execution of Master Batch Records, standard operating procedures and validation protocols.
• Ensure accurate completion of equipment logbook.
• Ensure cleanliness and proper assembly of manufacturing equipment per approved procedures (SOP’s)
• Responsible for ensuring safety of work area, and enforcing safety procedures.
• Ensures job deadlines and performance standards (for quality, productivity, reliability, initiative, safety, and work relationships) are met.
• Interface and consult with Quality Assurance personnel.
• Ensuring raw material containers are labeled correctly
• Report equipment malfunctions and Identify and report quality issues immediately
• Total compliance at all times by following batch records instructions, SOPs and all company policies
• Report accidents, unsafe conditions, or unusual circumstances to supervisor.
• Adhere to all relevant cGMP and FDA regulations.
• Maintain a neat and orderly work area at all times
• Comply with FDA guidelines/Company Policies of Data Integrity
• Other duties as assigned or delegated.

Other Responsibilities:

• Offer suggestions for process improvement when identified
• Other related duties as specified by supervisor in the area of granulation, compression, and liquid manufacturing as needed.

3. Education & Experience:

High School Diploma or equivalent or technical school certificate preferred

4. Technical competencies/ Certifications/ Licenses:

Technical competencies

• Excellent written and verbal communication skills
• Excellent math skills
• Ability to read and comprehend SOP’s, Batch Records and training documents.
• Ability to multi-task effectively
• Excellent interpersonal skills and ability to effectively interact with different functional groups

5. Physical demand and Work environment:

a. Physical demands:

While performing the duties of this job, the employee is required to walk, sit, and use hands to finger, handle or feel tools or controls, reach with hands and arms, balance, stoop, crouch, bend, talk and hear. The employee must lift and/or move up to 20 pounds. Specific vision abilities required by the job include close vision, distance vision, color vision, peripheral vision, and depth perception.

b. Work environment:

N/A