Quality Assurance Manager

Stokes Healthcare is a privately-owned business comprised of three divisions: Epicur Pharma (503B facility), Stokes Pharmacy (503A pharmacy) and STEP Labs Testing Facility. The divisions operate out of separate facilities in Mount Laurel, NJ, following different regulations and are guided by different principles. Stokes Pharmacy was founded in 1975. The pharmacy formulates custom prescription medicines for both humans and animals. The business has grown from a small, hometown operation in Medford, New Jersey, to a respected pharmacy serving the entire U.S., enabled by sophisticated online ordering and overnight shipping capabilities. In 2016, Stokes Healthcare built a world-class facility (which became Epicur Pharma), as a testament to the commitment to providing the highest level of quality.Adding a unique offering to the veterinary industry, Epicur Pharma is an FDA Registered 503B Outsourcing Facility, producing drugs such as Tacrolimus Eyedrops, Buprenorphine Injection and Gabapentin tablets. Epicur follows Current Good Manufacturing Practices (cGMP) which are the same rules and regulations followed by commercial manufacturers. Epicur Pharma is proud to be a pioneer in animal drug standards, offering the largest selection of manufactured drugs that are traditionally compounded. Epicur products are distributed directly to veterinary hospitals from our manufacturing facility and offered through Stokes Pharmacy for individual patient prescriptions. Stokes Healthcare has built a reputation for unwavering quality and superb service by holding fast to the founders’ commitment to traditional craftsmanship, combined with today’s most advanced knowledge and technologies. In a field where many corporate-owned pharmacies try to compete on price, Stokes has always put safety and quality first because patients’ lives depend on it. At Stokes, we offer competitive salaries and a comprehensive benefits package that includes medical, dental and vision coverage, life insurance, Health Reimbursement Account, Flexible Spending Account, 401(K) retirement savings plan with a generous employer match, a bonus program, paid holidays, paid time off (vacation and personal time), and an excellent working environment. We are conveniently located in Mount Laurel, New Jersey, just minutes from Philadelphia and the NJ shore. Job Title Quality Assurance Manager FLSA Status Exempt 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 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. 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 Affimitive Action Employer. #J-18808-Ljbffr