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Quality Specialist II

eTeam Inc.

Davie, FL

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JOB DETAILS
SKILLS
Cleaning Equipment, Communication Skills, Computer Workstations, Corporate Policies, Current Good Manufacturing Practice (cGMP), Data Analysis, Database Management Software/Systems (DBMS), Drug Manufacturing, Federal Laws and Regulations, GMP (Good Manufacturing Practices), High School Diploma, Lift/Move 25 Pounds, Maintain Compliance, Manufacturing, Manufacturing Operations, Manufacturing/Industrial Processes, Mobile Plant/Equipment, Operational Improvement, Operational Support, PC Software, Presentation/Verbal Skills, Printing, Quality Assurance, Reconciliation, Regulations, Safety Process, State Laws and Regulations, Team Player, Typing, Warehousing, Writing Skills
LOCATION
Davie, FL
POSTED
6 days ago
Job Title: Quality Specialist II
Location: Davie, FL 
Shift Schedule: Monday – Friday, 2:00 PM – 10:30 PM EST. Candidate must be able to work at least 2 weekends (Saturday & Sunday) per month. Training will be conducted during regular working hours.
Type: Contract
Duration: 6+ Months
Job Description
Core Essential Skills Needed
  • Experience as a Quality Assurance (QA) professional in a Pharmaceutical manufacturing environment (direct support to Manufacturing Operations).
  • Strong knowledge of Current Good Manufacturing Practices (cGMP).
  • Experience with complex pharmaceutical manufacturing processes including:
    • Granulation
    • Blending
    • Coating
    • Printing
    • Equipment Cleaning Verifications
  • Ability to work independently with minimal supervision.
  • Ability to bring knowledge and expertise to improve and transform operational areas.
Position Summary
Under general supervision, monitors compliance with Current Good Manufacturing Practices (cGMP) and Company policies, procedures, and specifications. Performs visual cleaning verification of equipment and manufacturing rooms.
Essential Areas of Responsibility
  • Carry out responsibilities in accordance with the organization's policies, procedures, and applicable State, Federal, and Local laws.
  • Conduct daily GMP walkthroughs and audits.
  • Perform walkthroughs of manufacturing rooms and conduct AQLs (Acceptance Quality Limits) as needed.
  • Place materials and finished products on Hold when required.
  • Review executed manufacturing records.
  • Perform cleaning verifications of manufacturing rooms and equipment as needed.
  • Perform additional related duties as assigned.
Education / Certification / Experience
Minimum Qualifications
  • High School Diploma or equivalent.
  • Two (2) years of experience in a manufacturing and/or warehouse environment
OR
  • One (1) year of satisfactory performance as a QA Inspector.
Skills / Knowledge / Abilities
  • Ability to establish and maintain cooperative working relationships with others.
  • Experience reading, reviewing, sampling, counting, calculating yields, and performing reconciliations.
  • Ability to read, understand, interpret, and comply with current Company policies, procedures, safety rules, and regulations.
  • Strong verbal and written communication skills.
  • Proficiency in operating a personal computer and database software.
Physical Requirements
Frequent
  • Sitting for extended periods of time at a workstation or while operating mobile equipment.
  • Standing for extended periods of time at a workstation or equipment.
  • Using fingers to perform activities such as picking, pinching, or typing.
Occasional
  • Walking short distances quickly and frequently.
  • Twisting/Reaching – turning at the waist and extending hands and/or arms in any direction.
  • Grasping – applying pressure to an object with fingers and palm.
  • Performing repetitive wrist, hand, and finger motions.
  • Lifting, raising, or moving objects horizontally up to 25 lbs.
Visual Acuity
Requires close visual acuity to perform activities such as:
  • Computer work
  • Preparing and analyzing data
  • Extensive reading
  • Visual inspection involving small defects and small parts
  • Operating machines (including inspections)
  • Using measurement devices
  • Assembly or fabrication of parts at close visual distances
Working Environment
  • Exposure to fumes, odors, dust, mists, or gases (non-office environment).
  • Exposure to moving mechanical parts and equipment.
  • Exposure to low, moderate, and loud noise levels.
  • May be required to wear appropriate Personal Protective Equipment (PPE) as required for the assigned area or process, including:
    • Safety glasses
    • Gloves
    • Hearing protection
    • Other required PPE

About the Company

e

eTeam Inc.

Looking for a great job? Join eTeam. We’re looking for talented staffing professionals to join our staff. We also provide contract assignments and full-time jobs at Fortune 2000 Companies. We’ve been named one of the best companies to work for by Staffing Industry Analysts and New Jersey Business.
COMPANY SIZE
100 to 499 employees
INDUSTRY
Other/Not Classified
FOUNDED
1998
WEBSITE
www.eteaminc.com

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