Quality Assurance Manager

Job Title

Quality Assurance Manager

FLSA Status

Exempt

Salary

Starting at $80,000 based on experience plus twice a year bonuses

Job Summary

The Quality Assurance Manager will oversee operations at STEP Labs Testing Facility. This includes, but is not limited to, managing quality systems, quality procedures relating to raw materials and products, method validations, managing day-to-day Quality Assurance operations, and the release of test reports within an analytical environment. This position leads the ongoing process focused on assessing, evaluating, and improving all aspects of quality management to enhance performance and maintain data reliability. The Quality Assurance Manager reports directly to the Laboratory Director/Managing Director.

Essential Duties and Responsibilities include the following. Other duties may be assigned.

• Ensure compliance with FDA regulatory guidance, ISO 17025, and company policies
• LeadregulatoryinspectionsandauditsbyFDA,applicableregulatorybodies,andaccreditation bodies
• DevelopQualityAssuranceprocedurestomaintaincomplianceandenhancereliabilityof laboratory procedures
• Monitoringapplicableregulatoryrequirementsforupdates
• Perform investigations for deviations, discrepancies, and out-of-specifications
• Lead investigations for deviations/discrepancies for laboratory departments
  • Perform root cause analysis using industry standards, such as FMEA, 5Whys and Fishbone diagrams
• Perform trend analysis of critical process parameters and evaluate KPIs to determine procedure effectiveness
• Assistinthedevelopmentandexecutionofrelevantcorrectiveandpreventativeaction
• Oversee training program to ensure staff is adequately trained and perform competency assessments as needed
• Ensure that the company policy for data integrity and ALOCA+ principles are met in the laboratory
• Overseeequipmentandinstrumentationcalibration,validation,andmaintenanceprogram
• Periodic review of data to comply with Laboratory Procedures, Test Method, Protocols, GxP, and work with personnel for any correction and promote a CGMP cultureLead in the development and implementation of new and existing processes:
  • Quality Management System
  • Sample Coordination
  • Laboratory Information Management System
  • Environmental Monitoring System
• Oversee the review and approval of testing documentation to support quality release of test reports in a timely manner
• Able to multitask, to work with dynamic changes of plans, to communicate with cross functional teams, complete the work within the timelines
• Overseechangecontrolmanagementprogramanddocumentationarchival
• WorkcloselywithQualityControltoevaluateallcustomerissues,performrootcause analysis and respond appropriately
• Leadindevelopmentandmaintainingofqualityinspectionprocessforanalyticaland microbiology testing
• Overseeperformanceofroutineauditsofprocessesandperformgapanalysis
• Monitorcontrolledsubstancechainofcustodytransfersthroughoutlaboratoryoperations
• Support Environmental, Health & Safety, and Logistic Teams

Required Education and Experience

• Minimum of 8 years of experience in analytical testing, microbiology testing, or pharmaceutical manufacturing, or applicable field, without a degree
• Minimumof6yearsofexperienceanalyticaltesting,microbiologytesting,or pharmaceutical manufacturing, or applicable field, with degree
• 3+years’experienceinasupervisoryrole,preferred
• Bachelor’sDegreeinBiologicalScience,Chemistry,BiomedicalEngineering,orrelevant field, preferred
• Excellentcommunicationandtechnicalwritingabilities
• ExtensiveknowledgewithGxP,FDA,ICH,ISO,USP,PDA,DEA,andOSHA requirements
• ProficientwithMicrosoftOfficeapplications(Word,Excel,etc.)
• Mustbecapableofwearingallprotectivewearasrequired.Thisincludes,butnotlimited to, mask, gloves, gown, hairnet, safety goggles, etc.
• Musthavestrongorganizationalskillsandexceptionalattentiontodetail
• Mustexhibitpunctualityandlowabsenteeism
• Abletoworkindependentlyandaspartofateam
• Abletosit,stand,squat,kneel,reachandwalkforprolongedperiodsoftime
• May need to lift up to twenty-five (25) pounds on occasion

Competencies

• Communication Proficiency
• Problem Solving/Analysis
• Quality Oriented
• Results Driven
• Technical Capacity
• Thoroughness
• Troubleshooting
• Time Management
• Employee Engagement
• Work Independently

Supervisory Responsibility

This position has supervisory responsibilities of the Quality Assurance Department.

Work Environment

This job operates primarily in the Quality and Manufacturing Areas. This position requires the use of standard office equipment, and frequent standing and walking.

Language Skills

Must be able to read, write, speak and understand English fluently and have the ability to read and interpret documents such as operating and maintenance instructions and procedure manuals.

Mathematical Skills

Uses addition, subtraction, multiplication and the division of numbers including decimals and fractions when checking reports, forms, records and comparable data where interpretation is required involving basic skills knowledge.

Reasoning Ability

Must have the ability to solve practical problems and deal with a variety of concrete variables in situations where substantial standardization exists. Must be able to interpret instructions furnished in written, oral, and diagram or schedule form.

Physical Demands

Thephysicaldemandsdescribedherearerepresentativeofthosethatmustbemetbyan employee to successfully perform the essential functions of this job.

• Abletositand/orstand8-10hoursormoreperdayasneeded
• May need to lift up to twenty-five (25) pounds on occasion

Position Type and Expected Hours of Work

This is a full-time position. Because of the nature of the business, work schedules may vary at times.

Travel

No travel is expected for this position.

Disclaimer

The above job description is intended to describe the general nature and level of work being performed by employees assigned to this job. It is not designed to capture or illustrate a comprehensive list of all responsibilities, duties, and skills required of employees assigned to this job.

AAP/EEO Statement

Stokes Healthcare is an Equal Employment Opportunity and Affirmative Action Employer.