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QA Specialist *$1,000 HIRING BONUS*

Marianna locationOmaha, NE
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21 positions
1 applicant
21 positions
1 applicant
info linkReport a probelm Originally Posted : September 17, 2021 | Expires : October 17, 2021


Job Type
Full-time Employee Show Shift
Mon: 8 am to 4 pm
Tue: 8 am to 4 pm
Wed: 8 am to 4 pm
Thu: 8 am to 4 pm
Fri: 8 am to 4 pm
Start Date
  • 401(k) Retirement Savings Plan
  • Dependent-Care Spending Accounts
  • Flexible Spending Accounts
  • Health-Care Spending Accounts
  • Profit Sharing
  • Dental
  • Dependent Life Insurance
  • Life Insurance
  • Long-Term Disability
  • Medical
  • Prescription Drug Plan
  • Short-Term Disability
  • Supplemental Insurance
  • Vision
  • Voluntary Life Insurance
  • Bereavement Pay
  • Continuing Education Program
  • Discounts on Employer Merchandise & Services
  • Employee Referral Program
  • Free Parking
  • Health Fair
  • Paid Holidays
  • Paid Vacations
  • Tuition Reimbursement
  • Unpaid Leaves of Absence
  • Wellness Program
  • Contact Details
    Name Kim Sanders
    Address 11222 I. St.
    City, State and Zip Omaha, NE. 68137
    Phone 402-593-0211
    FAX 402-537-9265
    Job Location
    Omaha, NE, United States


    $1,000 Hiring Bonus

    Job Summary:

    Perform Quality Assurance (QA) functions to build, uphold, and improve the Company’s Quality Systems.

    Essential Duties and Responsibilities:

    Applicable to all levels of position

    • Support the Quality System infrastructure by performing QA tasks pertaining to documentation of processes.
    • Perform Good Manufacturing Practices (GMP) compliance tasks, including audits, and documentation maintenance.
    • Perform internal supplemental audits to verify that facility records files are in conformance to applicable Standard Operating Procedures (SOP) and GMP regulatory requirements.
    • Perform training and manage the Quality System’s Training Program.
    • Ensure documentation systems used in QA are properly maintained (e.g., QA audit records, training records).
    • Perform protocol, data, and report inspections to verify conformance to applicable SOPs and GMP regulatory requirements.
    • Evaluate responses to Incident reports and perform follow-up with respondents, or others, if needed, to ensure resolution.
    • Make changes to SOPs, policies, training materials, and other documents in the records management system.
    • Assist during regulatory inspections.
    • Interface with various Divisions in problem resolution, and continual improvement.
    • Support manufacturing failure investigations, define investigational strategy.
    • Facilitate meetings.
    • Apply discretion in decision making.
    • Demonstrate independent judgment and make recommendations regarding business practices.
    • Formulate, implement, interpret and affect policies and operating practices.
    • Communicate effectively with others.
    • Maintain a good attendance record.
    • Perform work onsite.
    • Perform other duties as assigned.

    Quality Specialist 1 (Considered Entry Level Position therefore requiring most supervision/mentoring)

    Quality Specialist 2

    • Perform at an experienced and functional level therefore requiring limited supervision.
    • Engage in Professional Development Activities.

    Quality Specialist 3 (All Quality Specialist 1 and 2 skills as well).

    • Subject Matter Expert in Quality Assurance functions and GMP functions.
    • Function with little supervision.
    • Keep current on industry regulations.
    • Perform gap analysis of quality and analyze monthly trending reports of key quality indicators for manufacturing to ensure continuous quality improvement.
    • Recommend and implement modifications of existing quality or production standards to achieve optimum quality within limits of equipment capability, i.e. validation support.
    • Provide supervisor support on selected, large-scope projects involving data collection and/or research small scope individual topics drafting recommendations to QA management.
    • Mentor co-workers and internal customers with interpretation of regulatory requirements (e.g., Good Laboratory Practices (GLPs), SOP requirements, and other guidance documents, as applicable.
    • Notify management of quality/compliance trends and service failures.

    Quality Specialist 4 (All Quality Specialist 1, 2, and 3 skills as well)

    • Act as an alternate supervisor in supervisor’s absence.
    • Act as QA subject matter expert.
    • Make decisions autonomously.
    • Function without minimal supervision.
    • Function as a lead with the Supervisor present.
    • Develop and implement appropriate programs and systems.

    Required Education, Knowledge, Skills, Abilities:

    • Bachelor’s degree, preferably in Chemistry or in physical or biological science.
    • Minimum 3 years experience in an Food and Drug Administration (FDA) regulated manufacturing environment.
    • Minimum 1 year experience training in a business setting.
    • Minimum 3 years of progressive experience in Quality Assurance .
    • Demonstratable strong written and verbal communication skills.
    • Excellent organizational skills.
    • Proven record of excellent documentation skills.
    • FDA & OSHA trained and familiar with current regulations.
    • Strong problem solving skills.
    • Project management and technical software skills (Excel, Access, etc.) required.
    • Work well under pressure and able to prioritize workloads.
    • Ability to perform risk assessment.
    • Experiece fostering teamwork to get results.
    • Well organized and multi-task oriented.
    • Ability to work independently on multiple projects.
    • Ability to read, write and speak English competently.

    Preferred Knowledge, Certifications, Skills, Abilities:

    • Worked in pharmaceutical or cosmetic mfg environment.
    • American Society for Quality certifications.
    • Project management experience.
    • Experience training safety, quality and GMPs.

    Environmental Conditions:

    • Primarily office environment – climate controlled.
    • Periodic visits to:
      • Warehouse environment – some temperature extremes, dust and noise.
      • Manufacturing environment - some temperature extremes, dust, noise and wet.
      • Potential exposure to hazardous chemicals.
      • Requires use of PPE such as safety glasses, hairnets, or gloves.

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