Sr QA Specialist

3 days ago

New Delhi, India TekWissen LLC Full time
verview: TekWissen Group is a workforce management providerthroughout the USA and many other countries in the world. The belowjob opportunity is with one of our Biotech clients who researchesdevelop and commercializes drugs. The company focuses primarily onantiviral drugs used in the treatment of HIV hepatitis B hepatitisC and influenza including Harvoni and Sovaldi.
Position: Sr QASpecialist I Location: El Segundo CA 90245 Duration: 17 Months Job Type: Contract Work Type: Onsite Job Description
  • Client is seeking a Senior Specialist ofQuality Operations responsible for Product Disposition.
  • This position willparticipate in Quality activities to ensure compliance withapplicable quality objectives and regulatory requirements.
  • This position islocated at our El Segundo CA site and report into the AssociateDirector of Quality Operations.
Responsibilities
  • Perform Product Disposition andLot Closure. Includes commercial and clinical products.
  • Review batchrelated documentationand ensure resolution of issues to release product
  • Review batchrelated shipmentdocumentation to ensure product shipment remained incontrol
  • Provide QAoversight and review of deviations tied to lots. Ensure deviationsare properly initiated investigated and resolved in accordance withestablished disposition timelines.
  • Provide QA oversight and (limited) approvalof CAPAs. Ensures that associated CAPAs are initiated andresolved.
  • Provide QAoversight and approval of change records. Ensures that changerecords are initiated and resolved.
  • Support and participate in investigationsincluding batch record review.
  • Ensure process control measures are in place andfollowed in product manufacturing
  • Maintain metrics related to productdisposition in support of the Management Review
  • Generate and update proceduresforms and other documents
  • As assigned manage and provide QA oversight for otherprocesses including training warehouse/inventory redose new productintroductions etc.
  • Generate and report data for management
  • Maintain production (finite)disposition and team schedules
  • Represent Disposition or QA Ops at plant and multisitescheduling meetings
  • Provide QA representation on projects and at teammeetings
  • Provide QArepresentation at multisite disposition meetings
  • Support and participate ininspections and audits
Basic Qualifications
  • Masters Degree and 5 years ofexperience in GMP environment OR
  • Bachelors Degree and 7 years of experience in GMPenvironment OR
  • HighSchool Degree and 11 years of experience in GMPenvironment
Preferred Qualifications
  • Bachelors degree in the biologicalsciences or related field and minimum of 7 years progressiveexperience in a pharmaceutical biotech or biologics operation orequivalent education/work experience.
  • Working knowledge and ability to apply GMPsin conformance to standards
  • Ability to interpret and apply procedural and regulatoryguidance in potentially ambiguous situations
  • Ability to understand risk andprovide phaseappropriate appropriate decisions
  • Ability to effectively negotiateand build collaboration amongst individuals
  • Good interpersonal skills
  • Strong written communicationskills
  • Stronganalytical skills
  • Comfortable in a fastpaced small company environment andoperate with minimal direction
  • Ability to adjust workload based upon rapidly changingpriorities
NOTE: Position is Day Shift includingweekends and requires onsite presence. TekWissen Group is an equal opportunityemployer supporting workforce diversity.

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