Jobs

Description

100% Onsite

Shift: Monday - Friday 2:00 PM - 10:30 PM EST. Able to work at least up to 2 weekends (Sat and Sun) per month.

Training will be conducted during regular working hours.

Duration: 6 month assignment

Temp to perm: Based on openings and performance

Core essential skills needed:

• Experience as a QA in a Pharmaceutical environment (direct support to Mfg Operations)
• Strong cGMP knowledge with complex process in granulation, blending, coating, printing and equipment cleaning verifications.
• Experience working independently with minimal supervision and bring the knowledge and expertise needed to improve and transform the areas.

Position 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.

Essential Areas Of Responsibility

• 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:

Minimum Qualifications:

• 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.

Skills/Knowledge/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.

Travel Requirements: N/A

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 horizontally 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.

Working 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.).