QA Specialist I

LancesoftSan Diego, CA

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Job Description

SHIFT - MON-FRI 8AM - 4: 30PM - DURATION - 3 MONTHS -I. Position OverviewThe San Diego Clinical and Specialty Services (CSS) Quality Assurance Specialist I supports clinical trial projects, ensuring all work is performed in compliance with regulatory requirements, good manufacturing practices (cGMP) and standard operating procedures (SOPs). They are responsible for implementing and maintaining quality assurance processes throughout the product lifecycle. This involves ensuring that all documentation is accurate, up-to-date, and properly maintained in accordance with regulatory requirements.Education and Experience:Bachelor s degree required or equivalent relevant work experience.5-7 years of relevant work experience in a GMP environment, or comparable pharmaceutical knowledge and experience.JD Edwards or comparable ERP systems preferred.Minimum of 3 years of customer service experience.Proficient knowledge of MS Office software and query-based systems activities (e.G., Pivot Tables, VLOOKUP s, Excel Formulas, building presentations in PowerPoint, etc.).

Knowledge/Skills Requirements:

Receives instruction, guidance and direction from othersUses existing procedures to solve routine problemsProactive to address work issues at the individual levelAbility to follow a variety of instructions furnished in written, oral, diagram, or schedule formMathematical and scientific reasoning abilityAbility to identify aberrant data and potential quality/compliance concerns escalating to managementAbility to work effectively under pressure to meet deadlinesSufficient skills and knowledge in the use of computers and associated computer technology (Microsoft Office Software = Outlook, Word, Excel, OneNote, PowerPoint)Computer technology relates to both the hardware and software used in performing common computing tasks. (JDE, TrackWise, Smartsheets).Proficient in Adobe AcrobatProficiency in all QS I itemsProficient in JDEAble to create Certificate of Analysis independentlyInspection of bulk drug and finished productAdhere to GMP standards routinely with limited errors and limited guidanceAble to help with investigationsAble to communicate to other teams about requirementsPerform effective rapid responseSubject Matter Expert in JDE related to MMQC processesInspection of all incoming material typesInvestigation and Deviation writing proficientAuthoring/Updating documents related to MMQCApproval of GSA jobsIndependent release of labels for useApprove label printsApprove external label request formsVerify variable dataPerform effective rapid responseSubject Matter Expert in JDE related to label releaseInvestigation and Deviation writing proficientAuthoring/Updating documentsOne client

ApproachAssist with DME training for new associatesReviewing/approving Deviations and ComplaintsPerform effective rapid responseAttend/prepare for BRMsClient comment resolutions with assistanceDrive effective rapid responsesComplaint assessmentPresentation of Quality items to clients and ELTAssist with other site/global quality itemsAuthoring/Updating documentsTrain QS I and II associatesReviewing / approving engineering studiesReview/ approval of Periodic reviews and requalificationReviewing /approving change controls and change actionsPerform effective rapid responsePresentation of Quality items to clientsAssist with other site/global quality items

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FAQs About QA Specialist I Jobs at Lancesoft

What is the work location for this position at Lancesoft?

This job at Lancesoft is located in San Diego, CA, according to the details provided by the employer. Some roles may also include multiple work locations depending on the requirement.

What pay range can candidates expect for this role at Lancesoft?

Candidates can expect a pay range of $41.

What employment applies to this position at Lancesoft?

The employer has not provided this information. This may be discussed during the hiring process.

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