Quality Specialist II

Job Description

Job Summary:

• Under general supervision, monitors compliance with the current Good Manufacturing Practices and Company policies, procedures and specifications; performs visual cleaning verification of equipment and rooms.

Duties and Responsibilities:

• Carries out responsibilities in accordance with the organization’s policies, procedures, and state, Federal and local laws.
• Conducts daily GMP walkthrough and audit.
• Conduct walkthroughs of manufacturing rooms and perform AQLs – ( Acceptance Quality Limits) as needed
• Place material and products on Hold.
• Review executed manufacturing records.
• Performs cleaning verifications of rooms and equipment as needed.
• Responsible for performing additional related duties as assigned.

Education/Certification/Experience:

• High School Diploma or equivalent and two (2) years manufacturing and/or warehouse environment experience or one (1) year of satisfactory performance as QA Inspector.

Knowledge, Skills, and Abilities:

• Establishing and maintaining cooperative working relationships with others.
• Reading, reviewing, sampling, counting and calculating yields and reconciliations.
• Reading, understanding, interpreting and complying with current Company policies and procedures including safety rules and regulations.
• Communicating clearly and concisely, both orally and in writing.
• Operating personal computer and database software.

Physical Requirements:

Frequent:

• Sitting for extended periods of time at work station or mobile equipment.
• Standing for extended periods of time at work station or equipment.
• Using fingers to perform activities such as picking, pinching or typing.

Occasional:

• Walking to move short distances quickly and frequently.
• Twisting/Reaching – turning at waist and extending hands and/or arms in any direction.
• 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 Client tally up to 25 lbs.

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.

Work Environment:

• Exposure to fumes, odors, dusts, mists or gasses (for non-office).
• Exposure to moving mechanical parts or moving equipment.
• Exposure to low to moderate to loud noise levels.
• May be required to wear personal protective equipment (PPE) as needed for assigned area and/or process (i.e. safety glasses, gloves, hearing protection, etc.).