QA Lead Technical Operations

Synkriom, Inc.

Piscataway, NJ · HybridFull-time$175K/yrSeen 1w agoSeen in employer's feed 5 days ago

Piscataway, NJHybridFull-time$175K/yrSeen 1w agoSeen in employer's feed 5 days ago

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At a glance

Compensation

$175K/yr

Location

Piscataway, NJHybrid

Schedule

Full-time

Work Authorization

Not specified

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Requirements

Credentials this posting asks for.

Master's degree

Job overview

The QA Lead Technical Operations role provides quality assurance support to the Devens site, reviewing and approving investigations, corrective actions, SOPs, validation documents, and change proposals while ensuring regulatory compliance and guiding cross‑departmental teams.

Skills & qualifications

RequiredNice to have

Skills

Quality Assurance SupportQuality ReviewInvestigation ReviewCorrective Action ReviewDecision Making on Non‑ConformanceStandard Operating Procedure ReviewValidation Document ReviewRisk AssessmentProtocol ReviewTest Script ReviewSummary Report ReviewChange Proposal ReviewCross‑Department CoachingData InterpretationDefect ManagementRisk/Gap AssessmentValidation Deliverables OwnershipChange Control SupportDeviation Resolution (CAPA)Master Control – Quality Record Management SystemBlue MountainGxPData IntegrityAnalyzing & Visualization DataInformation SecurityRisk Management

Qualifications

Master's12 Months Experience

Benefits

Medical Insurance

Dental Insurance

Vision Insurance

401(k) Match

Full job description

Experience Required

12 months

Minimum Education Required

Master's

License(s) Required

Training Required/Provided

Compensation

$174,720.00 - $174,720.00 / Yearly

Hours Per Week

Number Of Positions

Shift

Unspecified

Job Description

QA Lead Technical Operations (Piscataway, NJ, or other unanticipated locations throughout the U.S.). Responsibilities include: Provide Quality Assurance (QA) support to Devens Site and reporting Manger through quality review and approval of Investigations and Corrective Actions. Responsible for decision making of non-conformance through a deep understanding of Quality Systems Regulatory expectations. Review and approve Quality, Quality Control, Validation and Automation related documents. Review and approve Standard Operating Procedures (SOPs). Review and approve Validation related documentation such as risk assessments, protocols and test scripts and summary reports. Review and approve change proposals as well as associated deliverables, ensuring the change deliverables meet external regulatory and internal WWQC guidelines and requirements. Coach across different departments within the subject matter of Investigations, CAPAs, general risk assessments and Validation. Interpret complicated data and make sound decisions. Telecommuting permitted. M.S. in Computer Science, Information Technology, or a related field. 12 months’ experience as QA Lead, Sr. Computer Systems Validation Engineer, Validation Lead, or a similar position. 12 months’ experience in: Defect management, Risk/ Gap Assessment, authoring and owning the validation deliverables for the change management, support Change Control, deviation resolution (CAPA), Master Control – Quality Record Management System, Blue Mountain, GxP, and Data Integrity. University coursework must have included: Analyzing & Visualization Data, Information security and risk management. 40 hrs/wk. 8:00 am – 5:00 pm. $174,720/year. Medical, dental, and vision insurance. 401(k). PTO/ sick leave in accordance with applicable law and company policy. Professional development and training opportunities. Send resume & salary reqs. to Synkriom, Inc. at: [email protected]. (Ref. code QALTO). No

phone calls please. EOE.