Specialist Quality Control

Payrate: $40.00 - $42.00/hr.


Summary:
The role involves supporting and troubleshooting issues at seven QC organizations in templating, template qualification, and using the established ELN Biovia SmartLab and consumable management systems. Responsibilities include reviewing and approving system user access, conducting periodic reviews, and authoring SOP revisions. The candidate will also collaborate with technology functions to resolve system issues, drive alignment across the QC network, and provide audit support. Expertise in data integrity requirements, problem-solving, and independent work is essential, with preferred experience in Biovia SmartLab and CIMS.


Responsibilities:

• Support of 7 QC organizations for templating, template qualification and use of ELN and consumable managament systems including troubleshooting issues
• Business owner review and approval of system (privileged, non-privileged) user access reviews, system periodic reviews, annual audit trail reviews
• Collaboration with technology function to ensure timely troubleshooting and resolution of system issues
• Authoring of SOP revisions related to the systems supported
• Review of system documentation for system changes (system description, design specification, requirements specification, data integrity assessment)
• Provision of input to deviations, and guidance on appropriate corrective/preventative actions
• Driving alignment and standardization across the QC network as it relates to the systems supported
• Review of training and submission of system access requests
• Lead biweekly network meeting
• Audit support
• Coordinate system downtime windows
• Development of queries/reports
• Review and approve application service/infrastructure requests, change approvals, problem records

Top 3 Must Have Skill Sets:

• Experience as business process owner
• Ability to problem solve and troubleshoot system issues
• Ability to work independently and deliver right first time results
• Knowledge of data integrity requirements of QC systems
• Ability to prioritize appropriately based on criticality
• Strong, clear, concise communication skills
• Document authoring and review capabilities

Preferred:

• Experience in Biovia SmartLab and CIMS
• Knowledge of SQL, tableau
• Audit support experience

Education/Experience:

• B.S. and minimum 5 YOE in QC.

Pay Transparency: The typical base pay for this role across the U.S. is: $40.00 - $42.00 /hr . Non-exempt positions are eligible for overtime at a rate of 1.5 times the base hourly rate for all hours worked in excess of 40 in a work week, or as required by state or local law. Final offer amounts, within the base pay set forth above, are determined by factors including your relevant skills, education and experience. Full-time employees are eligible to select from different benefits packages. Packages may include medical, dental, and vision benefits, health savings accounts with qualified medical plan enrollment, 10 paid days off, 3 days paid bereavement leave, 401(k) plan participation with employer match, life and disability insurance, commuter benefits, dependent care flexible spending account, accident insurance, critical illness insurance, hospital indemnity insurance, accommodations and reimbursement for work travel, and discretionary performance or recognition bonus. Sick leave and mobile phone reimbursement provided based on state or local law.


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