Quality Specialist II

Quality Specialist II

Duration: 06+ months contract on w2

Location: Davie, FL 33314

Temp to perm: Based on openings and performance

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.

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.

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).