Sign up menu

QA Supervisor

Marianna Omaha, NE
Apply

Quality Assurance Supervisor 

Flexible schedule 

$60,000 - $70,000 salary range 

$1,000 hiring bonus!

Job Summary: 

 

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

 

Principal Duties and Responsibilities:   

  • Manage an effective team.
  • Communicate information and projects up and down the chain of command.
  • Ensure proper staffing to support Quality Assurance functions and that staff receives appropriate training.
  • Evaluate team performance and competencies.
  • 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 at an experienced and functional level therefore requiring limited supervision.
  • Engage in Professional Development Activities.
  • 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.
  • Act as an alternate manager in manager’s absence.
  • Make decisions autonomously.
  • Develop and implement appropriate programs and systems.
  • Perform other duties as assigned.

 

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.
Instant Answers
providedProvided by company
Full-time Employee
Date Posted August 10, 2022
Date Closes September 9, 2022
Located In Omaha, NE
Department Quality
Job Type Full-time Employee
Shift Custom
Hours 40 hours per week
SOC Category 11-9081.00 Lodging Managers
Zipcode 68137
Name Beth Jarecki
Phone (402) 593-0211

This job offers the following benefits

  • 401(k) Retirement Savings Plan
  • Flexible Spending Accounts
  • Dental
  • Life Insurance
  • Maternity / Paternity / Family Leave
  • Medical
  • Vision
  • Casual Dress
  • Employee Referral Program
  • Free Parking
  • Paid Holidays
  • Paid Vacations

This job is related other jobs in these career categories

Apply
Benefits
  • 401(k) Retirement Savings Plan
  • Flexible Spending Accounts
  • Dental
  • Life Insurance
  • Maternity / Paternity / Family Leave
  • And More ...