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Quality Assurance Analyst 2

Company: US Tech Solution
Location: Raritan
Posted on: February 26, 2021

Job Description:

If you are interested to apply for this Job, please forward your updated resume - mounika.p@ustechsolutionsinc.com Job Title: Quality Assurance--Analyst 2 Location:--Raritan / NJ / 08869Duration: 12--Months ContractCompany: PharmaDescription:QA Associate--- Manage Document Control activities and projects--- Proactively evaluates and facilitates remediation of compliance risks--- May participate in change control as owner, assessor or approver--- Draft, edit and approve department procedures--- Responsible for assuring compliance to all relevant regulatory requirements (e.g., global cGMPs, DEA, EH&S) is monitored and gaps are mitigated--- May approve (or develop) cGMP training materials/plans for functional areas within JSC Stab Ops--- Participate in Lean initiatives as applicable and assist in driving Quality, Compliance and Lean thinking throughout Stability Operations--- May participate in process improvement activities including assessing current processes, providing improvement input and working with partners to implement changes.--- Provides training for Quality concepts or systems--- Monitors non-conformance and commitment data for trends--- Coordinates, maintains, reports and drives quality metrics--- Maintains inspection readiness system and activities for the site--- Participates in quality audits, inspection activities and responses.--- May participate in investigations as owner, reviewer, process owner, creating and driving metrics, and performing Quality review and approval of records--- Carries out duties in compliance with all local, state and federal regulations and guidelines including FDA, EMA, EPA, DEA, and OSHA--- Manages timeliness of local investigations, CPA, Change Controls (e.g., tracks open records and assures closure)--- Escalates issues to management in timely manner and works with management to address and remediate issuesKnowledge and Skill Set requirements include:--- Knowledge and understanding of current Good Manufacturing Practices (cGMP)--- Basic knowledge of analytical technologies used in the QC Stability laboratory--- Knowledge of global regulatory and compendial (USP, EP, JP, etc.) requirements--- Ability to manage an individual project with guidance from supervision/management--- Ability to read and interpret documents such as SOPs, work instructions, test methods and protocols--- Proficient with using Microsoft Office applications (Outlook, Excel, Word, and Powerpoint)--- Ability to makes GMP decisions both independently and with occasional guidance from QA supervision--- May occasionally assist the supervisor in establishing priorities--- Ability to influence others successfully--- Understanding of equipment qualification and computerized system validation processes and requirements--- Understanding of analytical method validation and transfer processes and requirements--- Proficient with Quality Systems for investigations/CPA management, change control, document management (e.g., Trackwise, ComplianceWire, DocSpace)--- Ability to write and/or effectively review/critique technical documents such as lab investigations with analytical and regulatory content as it relates to stability operations

Keywords: US Tech Solution, Trenton , Quality Assurance Analyst 2, Professions , Raritan, New Jersey

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