Supervisor, Quality Control

Alere San Diego , CA 92140

Posted 2 months ago

Supervisor, Quality Control

San Diego, CA

DO WORK THAT MATTERS

AbbottRapid Diagnostics (formerly Alere) is part of Abbott's Diagnostics family ofbusinesses, bringing together exceptional teams of experts and industry leadingtechnologies to support diagnostic testing which provides important informationfor treatment and management of diseases and other conditions.

Aswe embark on this exciting journey, the Abbott Rapid Diagnostic Division(ARDx) is searching for a Supervisor, Quality Control to join ourteam. This is a great opportunity to leverage your strong technical expertisewhile growing your career with a premier industry leader. If you seek a dynamicrole where your contributions will pave the way in developing exciting newproducts, then come and work with us!

Thisposition will work at the San Diego site, located in the beautiful SorrentoValley, where we manufacture critical protein and small molecule components formultiple Abbott Rapid Diagnostics products,with a focus on cardio metabolic diseases, infectious diseases and toxicology.

SUMMARY

Thisposition is responsible for supervising a production chemistry, quality controland/or laboratory department. You willbe part of a multi-shift supervisor team empowered to manage 24-hourmanufacturing operations. Position requires ability to jointly develop,implement, evaluate, and/or modify on going "best practices" to assure overalloperational effectiveness.

Youwill:

  • Be directlyresponsible for overseeing and managing daily chemistry or quality controlproduction in support of manufacturing goals and company objectives

  • Assureproduct is being manufactured efficiently, cost effectively and according toproduction schedule

  • Followand assure team compliance to all GMP's, safety, manufacturing and qualitysystem procedures directly related to the manufacturing process and filling outthe required supporting documentation associated with the products produced

TASKSAND RESPONSIBILITIES

  • Responsiblefor the day to day direction of Production Chemists, QC Analysts and

Technicians

  • Meetingproduction schedules, overall staff development, supporting product transfersand validations, implementing training and meeting dept. budgets.

  • Participatesin OPEX Initiatives and activities.

  • Generatingany necessary Quality Incidents, data extensions, rework forms, scrap formsetc.

  • Ensuringthat the manufacturing area is compliant with all required FDA, ISO and otherapplicable regulatory agency standards and documentation.

  • Responsiblefor ensuring that the manufacturing area is compliant with the requirementsassociated with EHS, HR, Facilities, Housekeeping, etc.

  • Monitorproduct performance during the production or testing run; direct productionpersonnel and daily activities to achieve production goals.

  • Establishand maintain department metrics.

  • Trainemployees according to established procedures; maintain attendance and trainingrecords.

  • Workclosely with temporary placement agencies to ensure that all training iscompleted and documented in a timely manner.

  • Initiatedisciplinary actions when necessary.

  • Documentand prepare performance evaluations.

  • Managedepartment expenses to achieve budget goals.

  • Ensurethat approved materials are available at all times to support production goalsand timelines. Will require close interaction with QA, Distribution, Planning,Purchasing and other internal departments.

  • Completionof daily cycle count program oversee counting activities and prepare reportsfor management review.

  • Developand initiate policies and/or procedures for continual metric improvement.

  • Assistwhen needed in both external and internal inventory audits.

  • Responsiblefor providing on-going training and guidance to staff.

  • Responsiblefor the ongoing FDA/ISO compliant, cost-effective manufacture of specificproducts or sup-products.

  • Reviewmanufacturing records for accuracy and completeness in accordance with GMP.

  • May beresponsible for fulfillment of daily/weekly production schedules.

  • Ensurethat the production or test processes are set-up and operating in accordancewith established procedures.

  • Ensure theaccuracy and effectiveness of inter- and intra- department communications.

  • Supportnew product transfer and validation and implementation of process improvements.

  • Performother duties and projects as assigned.

  • Demonstrates commitment to the development, implementation andeffectiveness of Alere's Quality Management System per ISO, FDA and otherregulatory agencies.

  • Carriesout duties in compliance with established business policies.

  • Managesperformance of staff towards department and Company goals, including feedbackon performance, appraisals, recommendations for merit increases or necessarydisciplinary actions, communication to employees on performance, etc.

  • Responsiblefor exhibiting professional behavior with both internal/external businessassociates that reflects positively on the company and is consistent with thecompany's policies and practices.

  • Performother duties & projects as assigned.

  • Understandsand is aware of the quality consequences which may occur from the improperperformance of their specific job. Has awareness of device defects that mayoccur in their area of responsibility, including product design, verificationand validation, manufacturing and testing activities.

QUALIFICATIONS/EDUCATION

  • BS inChemistry, Biology, or another related field

  • Minimum of 5 years manufacturing, chemistry, qualityassurance experience with at least 1- 3 years as a Lead or supervisor inlaboratory environment.

  • Knowledgeable of federal and other regulations, e.g.QSR's, ISO, ISO 13485, CMDR.

  • Works with semi-automated equipment.

  • Knowledge of MS Office and software systems used inmanufacturing

  • Basic understand of manufacturing systems (documentation,compliance, inventory control, production scheduling/controls, etc.).

  • Solid understanding of the product and manufacturingprocesses.

  • Prior experience with electronic inventory databasetransactions (i.e. Oracle, JDE, etc.)

About Abbott

At Abbott, we're committed to helping peoplelive their best possible life through the power of health. For more than 125years, we've brought new products and technologies to the world -- innutrition, diagnostics, medical devices and branded generic pharmaceuticals --that create more possibilities for more people at all stages of life. Today,99,000 of us are working to help people live not just longer, but better, inthe more than 150 countries we serve.

An equalopportunity employer, Abbott welcomes and encourages diversity in ourworkforce.

We provide reasonable accommodation toqualified individuals with disabilities. To request an accommodation, pleasesend an email to myrecruiter@alere.com.


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Supervisor, Quality Control

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