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Laboratory Quality Control Analyst

Company: Performance Cell Manufacturing, Inc.
Location: Poway
Posted on: November 23, 2021

Job Description:

Quality Control Analyst Job Description: Quality Control Analyst is responsible for working closely with the Quality Team members and/orSupervisor to assist in the maintenance and work of the Quality Control group at Performance Cell ManufacturingBiopharma, Inc. The Quality Control group functions include ensuring the quality, safety, and control of the products manufactured and processes performed at Performance Cell Manufacturing Biopharma. The Performance CellManufacturing facility is a GMP compliant facility that utilizes controlled clean room manufacturing of biological and regenerative medical products and Contract Manufacturing Organization services.Primary Responsibilities: Maintain the following systems: Environmental Monitoring of GMP facilityEnforce and support aseptic techniques and environmentPerform Quality Control inspections and testing (i.e. Endotoxin, Sterility)Help implement corrective actions and quality improvements related to Quality Control areas of responsibilityRecord keeping, organization and archivingSupport Quality with the day-to-day management of the following Organization of Quality Control test results to include sample submission for quality testingHelp with day-to-day control of records,Proficient in Microsoft Excel is preferredAssure that result data/files are complete, organized and reviewed in a timely mannerHelp trend quality test and environmental resultsAssist in investigations and quality control processesSecondary Responsibilities: Support Quality Staff with regulatory audits (FDA & State inspections), internal and external audits as needed.Support production and manufacturing activities as needed as a quality representativePerform additional job-related duties as requiredMinimum Requirements: 1-2 year(s) of experience in a quality role within a regulated cGMP laboratory environmentPrior experience within a biotech or a pharmaceutical company is preferredTeam minded individual with flexibility and dedicationDemonstrated ability to handle and prioritize multiple projects to meet deadlinesEfficient time management and organizational skillsSolid verbal communication skills with the ability to clearly apply written communicationUnderstanding of the field of cell therapy processing preferredAnalytical skills and solutions-oriented approach to problem-solvingAbility to work effectively in a fast-paced, rapidly changing environment with othersDemonstrated ability to work independently as well as part of an integrated teamPosition may require some "off-standard hours"-- -Reports to: Quality Control Manager Minimum Experience: 1 - 2 yearsMinimum Degree: Associates degree in scientificTravel: Not applicable related field or equivalent experience.Full-time Exempt Schedule: 8am to 5pm Mon - FriPart-time N o n - e x e m p t O t h e r :Quality Control Anaylst Page 1Responsibilities: Other Duties The preceding functions have been provided as examples of the types of work performed by employees assigned to this position. To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed in this description are representative of the knowledge, skill, and/or ability required. Management reserves the right to add, modify, change or rescind the work assignments of different positions due to reasonable accommodation or other reasons.Physical Demands: The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.While performing the duties of this job, the employee is expected to: Light to moderate work - Exerting up to 50 lbs of force occasionally, and/or up to 10 pounds of force frequently, and/or a negligible amount of force constantly to move objects.Lifting, Carrying, Pushing, Pulling and Reaching:Occasionally: Reaching upward and downward, Push/pullFrequently: Stand, SitConstantly: N/AActivities:Occasionally: Handling, Push/pull, reaching upward and downward, Talking - ordinary, loud/quick, WalkingFrequently: Sitting, StandingConstantly: N/AEnvironmental Conditions:Occasionally: Gowning for entry into cleanroom environmentsFrequently: N/AConstantly: N/AWork Environment: The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.Noise Intensity: ModerateOccasionally: Production/manufacturing environmentFrequently: N/AConstantly: Lab and office environmentQuality Control Anaylst Page 2Job Type: Full-timeBenefits:401(k)401(k) matchingDental insuranceFlexible spending accountHealth insuranceLife insurancePaid time offTuition reimbursementVision insuranceSchedule:Day shiftEducation:Associate (Preferred)Work Location: One location

Keywords: Performance Cell Manufacturing, Inc., Poway , Laboratory Quality Control Analyst, Professions , Poway, California

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