Quality Specialist I

Role Summary

This position is responsible for the execution of the sampling function in the warehouse. Other warehouse activities including shipping, receiving, material staging, inventory maintenance and record keeping in compliance with all regulatory requirements and company policies and procedures is also required.

Responsibilities

• Responsible for receipt and sampling of all raw materials, other chemicals and supplies.
• Responsible for maintaining and moving sample quantities in electronic system.
• Responsible for ensuring that materials are staged properly for production areas.
• Responsible for loading and unloading trucks and other vehicles delivering or picking up controlled and non-controlled substances from the premises.
• Responsible for completing documents required in Production, QC and R&D, and updates to all manual and automated records as required.
• Responsible for granting access of authorized individuals to controlled substance storage areas.
• Responsible for assisting in additional warehouse activities such as shipping, receiving, staging and inventory maintenance as needed.
• Responsible for completing training requirements and maintaining 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 performing additional related duties as assigned.

Qualifications

• Requires High School Diploma or equivalent.
• Minimum of 1 year warehouse or related experience in a manufacturing environment preferably within the pharmaceutical, nutraceutical or food processing industries.
• Prefer forklift experience/certification.

Skills

• Basic computer skills with working knowledge of MS Office products (additional experience with systems such as LMS, ERP, etc. preferred).
• Ability to receive instruction and follow directions.
• Ability to interact positively with co-workers and management.
• Ability to communicate effectively with written and oral communication skills.
• Ability to follow company policies and procedures.
• Ability to follow cGMP and other regulatory requirements.
• Ability to read and interpret documents and make basic judgments on the suitability of received goods.
• Ability to operate and troubleshoot warehouse equipment.
• Detail oriented with ability to identify errors and/or inconsistencies while performing tasks.

Education

• High School Diploma or equivalent.

Additional Requirements

• Travel Requirements: N/A
• PHYSICAL REQUIREMENTS:
  • Standing for extended periods of time at work station or equipment.
  • Walking to move short distances quickly and frequently.
  • Stooping, Kneeling and/or Crouching – bending body, spine and/or legs.
  • Grasping – applying pressure to an object with the fingers and palm.
  • Using fingers to perform activities such as picking, pinching or typing.
  • Climbing – use of feet, legs, hands and/or arms to ascend or descend.
  • 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. and more than 50 lbs (with assistance).
• Sitting for extended periods of time at work station or mobile equipment.
• Visual Acuity: Perform activities such as operating machines, computer work, visual inspection involving small defects, and use of measurement devices.
• WORKING ENVIRONMENT:
  • Frequent exposure to moderate to loud noise levels.
  • Constant exposure to moving mechanical parts and/or moving equipment.
  • May be required to wear personal protective equipment (PPE) as needed for assigned process (i.e. safety glasses, respirator, hearing protection, gloves, etc.).