Director of Quality Control

Farmington, CT

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Description

Westaff is seeking a Quality Control Director. The Director of Quality Control is responsible for coordinating all phases of quality control for overseeing the manufacturing and distribution of our products,overseeing the activities of the quality control laboratory, documentation control department and regulatory functions.The products manufacture dare dietary and food supplements in a batch manufacturing environment.

 

MAJOR FUNCTIONS/RESPONSIBILITIES for the Director of Quality Control 

 

  • Oversee compliance and implementation of the FDA Current Good Manufacturing Practices including but not limited to (cGMP)21CFRPart111.
  • PromotecGMPcompliancethroughtrainingandmonitoringStandardOperatingProcedures(SOP) effectivily.
  • ProvidetrainingfornewandexistingpersonnelinFDAcGMP21CFRPart111 and other applicable regulations as required.

 

  • Meet with the production manager,department supervisors,and production personnel to review SOPs, Training, and implement cGMP compliance and continuous improvements.
  • Issue Corrective and Preventive Action’s to applicable departments as required. Assist in reviewing and/or completing CAPA’s and implementing the findings to make systematic improvements including but not limited to updating applicable SOP’s and conducting training.
  • Manage the internal audit program and participate in 3rd party and FDA audits.
  • Train personnel in quality control/assurance and lead continued improvement in this area.
  • Write and/or edit SOPs as required and lead bi-annual review of all SOP’s.ProvidetrainingandguidancetoothersonwritingandreviewingSOPs.
  • Review SOPs for completeness and compliance to cGMP and other applicable regulations.
  • Assist or lead the hiring, performance improvement plans and terminations of employees in reporting departments.
  • Representative on all company safety committees.
  • Participate and/or lead internal and external audits.
  • ManageDocumentControlactivityincluding:
    •  MasterManufacturingRecords(MMR)andBatchProductionRecords(BPR).
    • Rawmaterialandfinishedgoodsspecifications,trainingdocuments, environmental control, incomingandfinishedproducttestresultsandreleases.
    • Oversee and verify batch record for accuracy and completeness.
  • Reviewandfiling ofcompletedbatchrecordsandspecificationlogs.

 

  • ManageRegulatory activitiesincluding:
    • Gainingproductapprovalof3rdpartiesandforothernations.
    • Insuretimelyand accurateresponsetocustomersupport activitiesincludingCertificates of Analysesand customercomplaints.
  • DirectQualityControlLaboratoryactivityincluding:
    • Rawmaterialandfinishedproducttestingtoinsureproductmeetsallqualityrequirementsandlabelclaims.
    • Workwithprocurementtoensureconsistentquality inrawmaterials as required.

 

  • Oversee and check in in-coming raw ingredients to verify they match specifications and Certificate of Analysis
  • Determine need for 3rd party laboratories testing and develop approved 3rd party laboratories list.
  • Insure appropriate laboratory testing is completed and expand testing capability when appropriate.
  • Expeditetestingprocesswhennecessary
  • Insure samples are collected and retained for each product and raw material 
  • Maintain and monitor regulatory activity
  • Other duties as required

 

 

Job Requirements

QUALIFICATIONS of Director of Quality Control

 Bachelor of Science degree in nutrition or field of science with five years' experience in quality control/assurance in dietary supplements or other similar regulated field.

Prior Experience managing and leading multiple departments and professional technical employees.

 

SPECIFIC SKILLS for the Director of Quality Control

 Communication(oral and written),mathematical computations,problem solving analysis, reading comprehension, organization, self-starter, mobility,supervisory,general office equipment including computer hardware and software skills,specifically Microsoft Office are required.

Knowledge of statistical sampling techniques and statistical writing is a plus.

Ability and willingness to working a variety of situations including one-on-one, group, face-to-face via person,oralandwrittencommunications.Interactionsoccurwithemployeesofalllevels as well as external partners.

Highly motivated person who is able to multi-task and handle a high volume of work with accuracy in a fast-changing environment.

Demonstrated skills and proven past results in managing multiple departments, locations and professional employees.

Prior experience writing and editing SOP’s, training people, issuing and performing CAPAs, and performing and overseeing systematic improvements.

Prior experience conducting audits and participating in audits.

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