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SUPERVISOR, MQA - 2nd Shift

SUPERVISOR, MQA - 2nd Shift

Fresenius Kabi USA, LLCGrand Island, New York, United States
4 days ago
Job type
  • Full-time
Job description

Job Summary

  • 2nd Shift is 2 PM to 10 : 30 PM, Monday through Friday
  • Salary Range : $73,614 - $103,000 Annually + 6% Bonus
  • Final pay determinations will depend on various factors, including, but not limited to experience level, education, knowledge, skills, and abilities.

Responsible for supervising the activities of MQA Specialists. Ensures performance of audits and SOP / GMP compliance at the Grand Island manufacturing facility. Performs investigations as required to ensure product quality. Performs analysis on quality indicating data and makes recommendations for improvement. Assists in the accurate and timely batch release of manufacturing batch record documentation.

Responsibilities

  • Supervises daily activities of MQA Specialist. Assures job objectives are met on a timely basis.
  • Performs and oversees the training of personnel. Effectively hires, develops, counsels, manages and motivates staff. Writes and administers performance appraisals for department personnel.
  • Assures standard operating procedures (SOPs) define the steps necessary to complete tasks, etc. Writes reviews and approves SOPs.
  • Follows up with department management to ensure appropriate corrective action is implemented for audit observations and documentation issues.
  • Assures execution of monitoring and testing procedures to assess the physical quality characteristics of in-process / finished products, environmental parameters, and production / packaging processes.
  • Performs analysis on monthly quality indicating reports generated by MQA Specialists. Makes recommendations for improvement. Follows up on corrective action with departmental management.
  • Develops systems to facilitate timely finished product disposition.
  • Performs investigations as required. Follows up to ensure corrective action is implemented. Initiates / supports management meetings / projects to facilitate timely product disposition.
  • Performs gown qualification and maintains status for entry into Aseptic processing area in order to complete facility and processing audits of all job functions. This will also include all other areas of production, as well as the laboratories for risk analysis.
  • Performs AQL checks on product when necessary and maintains AQL qualification status.
  • Troubleshoots manufacturing problems and quality issues. Works with Operations personnel to investigate, collect and analyze data for, resolve and implement corrective action. Contacts supplier and / or outside laboratory for investigational support.
  • Provide deviation / EOD / EE / Action Plans review and approve function for Quality Assurance and determines impact on product disposition.
  • Maintains knowledge of current GMPs and regulatory guidelines.
  • Performs supplemental investigations / projects as required by management
  • All employees are responsible for ensuring the compliance to company documents, programs and activities related to Health, Safety, Environment, Energy and Quality Management System as per your roles and responsibilities.

    • Requirements

  • Bachelor of Science Degree or ten (10) to fifteen (15) years equivalent education / professional experience required.
  • Knowledge of legal and regulatory requirements governing the manufacture of pharmaceutical products.
  • Must be knowledgeable of quality control testing methods, validation techniques, and physical testing methods / concepts.
  • Must be able to understand the significantly interpret data utilizing analytical skills and practical experience in pharmaceutical application.
  • Requires three (3) to five (5) years of progressive responsibility in quality to support pharmaceutical manufacturing processes.
  • Demonstrates leadership qualities. Supervisory experience preferred.
  • Understanding that error in analysis, judgment or decision making could result in serious implications including Regulatory issues, product recall, product liability and significant dollar loss
  • Computer skills required.
  • Excellent verbal and written communication skills required.

    • Additional Information

    We offer an excellent salary and benefits package including medical, dental and vision coverage, as well as life insurance, disability,401K with company contribution, andwellness program.

    Fresenius Kabi is an Equal Opportunity / Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, citizenship, immigration status, disabilities, or protected veteran status.

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    Supervisor 2Nd Shift • Grand Island, New York, United States

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