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Lab Application - Rochester, United States - Unifin SAS
Description
Lab Application & Quality Control SupervisorWho we are?We are a French pharmaceutical industrial group, recognized for making affordable healthcare products that improve and simplify patients' lives to as many people as possible.
With 30 years of technological expertise, we position ourselves as a world leader in sterile single dose with 10 sites on 4 continents and more than 2000 employees.
Since 2013, our site Unither Manufacturing LLC. based in Rochester (NY), specializes in the manufacture of Blow-FillYour roleReporting to the Quality Control Manager,The Laboratory Application & QC Supervisor ensures that all laboratorysystems composed of equipment, instruments and computerized systems areproperly maintained, qualified, calibrated, secured to be properly used by thelaboratory users while ensuring a high level of confidence with productresults.
Provide access management for each computer system, while ensuringdata handling and data integrity. This position partners as the laboratorysystem owner with the IT group.Ensuring all laboratory systems are properly usedin chemistry and microbiology, while assisting laboratory staff with technicalissues, and training on the systems.
Provides recommendations on efficienciesand all secured data.ESSENTIAL FUNCTIONS / RESPONSIBILITIES:
LaboratoryComputerized Systems ManagementManage all software upgrades and laboratory computerized systems and qualificationManage user accounts and train technicians on existing software, check access at regular intervalsValidate the excel calculations used in QCCreate instrument control methods Perform system audit trails of the various systems in placeEnsuring compliance with data integrity requirements in the control laboratoryManage contracted external suppliers for certain interventionsLaboratorySystems Technological SurveillanceManage the proper functioning of each instrument and ensure all equipment complies with applicable standardsEstablish user requirement specifications for systems replacementManage maintenance interventions; establish a maintenance contract with the supplier if it cannot be carried out in-houseManage requests for quotations and orders for the purchase and repair of laboratory equipmentOrder new equipment after evaluation and approval by the QC ManagerEnsure the condition of equipment and participate in the investment budgetLaboratorySystems Calibration, Maintenance and Qualification Manage all scheduled updates with the laboratory scientists and supervisors, at least annually, to ensure calibration and maintenance specifications.
Perform tests or supervise the execution of tests and issue appropriate reportsPlan interventions with suppliers or perform checks according to the defined scheduleManage external suppliers, when applicableSourcing consumables needed for operationsVerify and sign metrological reports from our subcontractorsWrite and/or evaluate deviationsProviding calibration labelsVerify and sign vendor qualification protocols and reports and/or draft protocols in-houseProviding the pre-authorization and support to Lab Operations, as neededWrite requalification paperwork Apply GMP training receivedQualityrequirements and improvementsParticipate and support metered instrument updates, as neededParticipate in audits and inspections and propose CAPA plan timeline and ensure a timely execution.
Maintain the laboratory qualification/validation/calibration master plan Lead or participate in working sessions and projects (laboratory projects, sites projects), after agreement of your managementAnalyze the processes in place and the working methods in place, and propose improvements to improve the compliance and / or efficiencyUpdate by yourself all types of documents for your perimeter, and lead the execution of actions Support the development of new products by participating in the development/validation/optimization of methods and by integrating new instrumentsHealth& SafetyRespect and ensure compliance with dressing and hygiene proceduresRespect and ensure compliance with safety instructions and various proceduresEnsure compliance with safety rules during interventions or when writing the various standards and proceduresHave an appropriate attitude that does not endanger your safety and the safety of othersReport any discrepancies or risks you may findSPECIFICSKILLS:
Must have previous experience in cGMPenvironmentStrong knowledge andinterest in testing softwareAbility to evaluate data, perform trend analyses, identity potential issues, propose and implement solutions.
Ability to comply with SOP's, cGMP's, HS&E requirements, and FDA, DEA, and OSHA regulations.Ability to work independently or within a group project team setting.
Your profileQUALIFICATIONS/EXPERIENCE:
Bachelors degree in Life Sciences preferred5-10 years of laboratory experience, in development, chemistry or stability, including validation, qualification and calibration purposes Software and instruments interests, especially HPLC and GC knowledgeQuality Control/Assurance, Stability and GMP experience preferred.
Technical knowledge to review and analyze stability test results Ability to write and provide input for deviations, investigations and CAPA's as neededStability experience in pharmaceutical manufacturing or medical device background requiredCompensation range87, ,000.00 USD *The referenced compensation range represents the minimum and maximum compensation for this job.
Individual annual salaries/hourly rates will be set within the job's compensation range, and will be determined by considering factors including, but not limited to, market data, education, experience, qualifications, expertise of the individual, and internal equity considerations.
Learn more about us:
We are a dynamic company driven by a spirit of victory and are therefore pursuing strong growth while maintaining a close relationship with our customers and employees.
Our culture is based on 5 values:
Respect, Responsibility, Trust, Courage and Innovation.
We are committed to bringing these values to life with our employees by granting them a high degree of autonomy in the exercise of their profession and by encouraging their initiatives.
We are committed to providing them with working conditions and atmosphere that is conducive to their development and the expression of their potential.
We propose you to integrate a site that values the meaning of work and that entrusts our employees with a high level of responsibility.
Join us and make a difference
