Quality Associate
: Job Details :

DescriptionNatureplex is a privately held OTC pharmaceutical manufacturing company that was first started in 2001 and has been growing exponentially each year. We offer our own label as well as private label and contract packaging of enemas, feminine hygiene products, over-the-counter medications, and personal care products. We currently have two locations, one in Olive Branch, MS just a few miles from Memphis, TN and a location in Memphis, TN. We are rapidly growing which means there are opportunities for advancement. We currently have an immediate opening for a Quality Associate at our Memphis, TN location.We offer benefits that include:Medical Insurance (we pay 80% employee coverage and 20% for dependent coverage)Dental insuranceVisionVoluntary LifeShort Term DisabilityVacation6 Paid Holidays401(k) with Company MatchCompany paid life insuranceWeekly PayNatureplex is an equal opportunity employer. Natureplex participates in E-Verify.RequirementsSummaryResponsible for performing quality checks, system tests, integration testing and performance testing.Essential FunctionsPerform compounding room, production line and finished goods inspection as required per SOP.Verify that issued components to the production lines are correct.Sample, inspect, and release/reject incoming components and raw materials.Verify that outgoing shipments are correct.Coordinate and provide production paperwork for reconciliation with respective batch record(s).Cross-train to:Independently issue, review, reconcile and approve product quality documentation such as master batch records (inclusive of filling and packaging paperwork) as required.Create product formulations, blend sheets, and CofA templates as required.Scan, verify, file and archive documentation as needed (such as graphics, Batch Records, Validations, Qualifications, Formulations, CofAs, CAPAs, Incident Reports, Customer Feedbacks, etc.)Data Entry for Annual Product Review.Review documentation for GDP and ALCOA compliance (i.e. production and compounding log books)Supports the maintenance of monthly document control metrics.Investigate inventory discrepancies.Provides support with internal and regulatory audits/inspections.Adhere to cGMP (current Good Manufacturing Practice), FDA (Food and Drug Administration) and CPSC (Consumer Product Safety Commission) requirements.Participates as required in training on issues affecting own area of work.Notifies manager of compliance questions and issues.Other duties as needed.CompetenciesDecision MakingTeamworkWork StandardsMotivationReliabilityProblem SolvingAdaptabilityCommunicationIntegrityInitiativeStress ToleranceSkills, Knowledge, AbilitiesGood communication and interpersonal skills; Self-reliant and motivated self-starter.Project and task oriented with a focus on details, timely execution of projects.Ability to work well within group or individually on projects.Microsoft Excel, Microsoft Word; Microsoft PowerPoint.Work EnvironmentManufacturing Environment - hot and cold conditions; some strong odors.Equipment Used and Physical DemandsModerate physical activity requiring reaching, sifting, lifting, finger dexterity, grasping, feeling, repetitive motions, talking and hearing.20% or more time spent looking directly at a computer and/or typing.80% or more time spent standing, walking (or otherwise being mobile).Expected Hours of WorkMonday - Friday, 40 hours; Overtime when needed.TravelSome local between facilities.Required Education and ExperienceHigh School diploma or equivalentAssociate Degree in a related field, preferredThree - five years' experience in a relevant cGMP and FDA industry#J-18808-Ljbffr