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Top 50 Senior Associate Quality Assurance Skills

Below we've compiled a list of the most important skills for a Senior Associate Quality Assurance. We ranked the top skills based on the percentage of Senior Associate Quality Assurance resumes they appeared on. For example, 8.5% of Senior Associate Quality Assurance resumes contained Test Cases as a skill. Let's find out what skills a Senior Associate Quality Assurance actually needs in order to be successful in the workplace.

These are the most important skills for a Senior Associate Quality Assurance:

1. Test Cases

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high Demand
Here's how Test Cases is used in Senior Associate Quality Assurance jobs:
  • Authored and executed Validation test cases required for system implementation and upgrades which shortened testing time during validation schedule.
  • Design the detail-oriented Test Plans, Test Scenarios, Test Cases based on the product backlog and technical specifications.
  • Prepared Test Plan and Integration Test Plan, provided support to QA team to execute automated test cases.
  • Created and executed test cases, analyzed and reviewed written test cases and provided feedback to team members.
  • Use SpiraTeam to create and store requirements, stories, tasks, test cases and incidents.
  • Test Cases are used for testing the system that will be moved into Production.
  • Executed parallel test cases on real and virtual devices for Android and IOS platforms.
  • Develop and Execute Test Plans, Test Cases, Test Sets and Test runs.
  • Modify the test cases according to the present working condition of the application.
  • Designed Manual Test Cases in Visual Studio MTM (Microsoft Test Manager).
  • Involved in understanding the requirements and developing test cases based on the requirement.
  • Used various tools like TAU and DSL to develop automation test cases.
  • Input values from test cases to the database to ensure correct premiums.
  • Write Test Cases and Test Scripts for the robust Application.
  • Automated Test cases, condition and test data Designer iii.
  • Peer reviews of the test cases.
  • Planned, created and implemented test cases for the PenFed mobile banking application (Android, iOS and Mobile Web).
  • Utilized Apache POI jar file to read data from the excel spread sheets and load them into required test cases.
  • Oversee Test Execution and Test Automation Review the Test Cases for Manual and Automated Business Process Testing.
  • Maintained the Traceability Matrix between Requirements, Design Components, Test Cases and Defects.

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2. QA

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high Demand
Here's how QA is used in Senior Associate Quality Assurance jobs:
  • Trained/mentored QA staff and educated QA/operations staff on quality principles and regulatory requirements.
  • Represented QA in change control, standardization and consolidation activities to ensure implementation occurs in a state of compliance.
  • Assisted in the scheduling and maintenance of QA activities and systems among laboratory and plant manufacturing processes.
  • Assure the timely QA review of equipment log books, maintenance records, and calibration documentation.
  • Provided QA Support for the qualifications of 71 Manufacturing Associates in order to increase commercial production.
  • Participate as a QA representative in the Operational excellence tool DiD for the packaging area.
  • Lead internal QAU inspections; conduct study, process/method, and facility based quality audits.
  • Trained new staff within QAL, Manufacturing, and Validation in SM&R procedures.
  • Reviewed equipment protocols (IQ/OQ/PQ) on Instrumentation Validation team during redeployment in PQA.
  • Execute PQA (Plant Quality Assurance) task in EBR program and track-wise.
  • Participated in project team meetings as technical expert representing the QA Department.
  • Collaborated with QA Manager to establish and implement QA Policy.
  • Compile QA/Regulatory data and create reports for complaint trending.
  • Perform QA in-process inspection during the packaging process.
  • Represent PQA in the manufacturing production meeting.
  • Represented QA in management meetings.
  • Lot Disposition rep for SM&R by working with QA to review/approve specs and C of A's.
  • Serve as Plant Quality Assurance (PQA).
  • Participate as QA representatives in Kaizens process for reduce the changeover time in the packaging vials line.
  • Represent QA on Project Team for oncologic drug candidate.

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6 QA Jobs

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3. Batch Records

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high Demand
Here's how Batch Records is used in Senior Associate Quality Assurance jobs:
  • Review completed batch records, Environmental Monitoring data, laboratory records and other ancillary data for product release.
  • Managed completed Batch Records and supporting documentation review activities required for product disposition.
  • Review batch records for product packaged at secondary packaging facilities.
  • Reviewed and approved Manufacturing batch records and calibration documentation.
  • Reviewed and approved Batch production Records and Electronic Batch Records to ensure compliance with company Standards Operating Procedures and GMP regulations.
  • Review and approval of intermediates batch records, test records (microbiological and chemical), policies and procedures.
  • Revise and review GMP controlled documents including Standard Operating Procedures, Batch Records and Test Methods for cross-functional departments.
  • Conducted review of completed batch records and quality control test records for batch release.
  • Perform final review and approval of batch records to ensure GMP and GDP compliance.
  • Reviewed and approved master batch records, controlled forms and standard operating procedures.
  • Issue, verify and review clinical and commercial drug product batch records.
  • Review and approve batch records and COA's.
  • Review the BATCH RECORDS at various stages.
  • Review manufacturing batch records and analytical data.
  • Reviewed and approved Drug Substance, Drug Product, Analytical and Package and Labeling Batch Records to assure compliance and completeness.
  • Manage quality documents such as batch records, test methods, product labels and other documents for cGMP activities.
  • Reviewed and approved GMP Controlled Documents including SOPs, Batch Records, and Test Methods.
  • Reviewed SOPs, batch records and test techniques.
  • Audited / reviewed production batch records for accuracy and adherence to SOPs and cGMPs.
  • Issue batch records and review upon completion for adherence to cGMPs and SOPs.

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3 Batch Records Jobs

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4. Ensure Compliance

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high Demand
Here's how Ensure Compliance is used in Senior Associate Quality Assurance jobs:
  • Monitored day-to-day operations to ensure compliance with cGMP's.
  • Monitor production area to ensure compliance with cGMP.

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5. Audit Procedures

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6. Capa

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Here's how Capa is used in Senior Associate Quality Assurance jobs:
  • Drafted and revised Standard Operating Procedures related to CAPA and Deviation Management.
  • Oversee customer complaint/Adverse Event process/investigation/CAPA.
  • Performed Investigation, Root Cause Analysis, and CAPA for Incident and Loss Program and non-conformance materials.
  • Developed and implemented self-audit programs, including sharing of findings and determination of proper CAPA.
  • Organized and presented information and problem solving sessions for responses to NCR/CAPA issues.
  • Investigated deviations and recommended corrective and preventive actions (CAPA).
  • Managed the CAPA process: investigation, completion and effective implementation.
  • Identified and documented problems; completed and monitored CAPA activities.
  • Managed the company CAPA program including procedure authoring.
  • Investigate manufacturing deviations and develop suitable CAPA's.
  • Resolve quality issues and implement CAPA's.
  • Developed and facilitated implementation of appropriate corrective and preventive actions (CAPAs); developed plans for verification of CAPA effectiveness.
  • Review and approve internal quality investigations related to Inventory Management along with tracking all Capa's associated with incidents.
  • Collaborated with Compliance Manager in the review of CAPA documents to meet Current Good Manufacturing Practices (cGMP) requirements.
  • Conducted / approved investigations and initiated CAPAs in support of QAL Microbiology, Critical Reagents, and Support Labs.
  • Provided training for Pilgrim eQMS ER & CAPA software, Investigator Training and departmental procedures.
  • Performed QA Closure Approval for Deviations & CAPAs related to R&D products.
  • Review of Deviations, CAPAs, Complaints, and Quality Control investigations.
  • Review and approve laboratory investigations, deviation reports and CAPAs.
  • Root Cause Analysis and NC, CAPA Responsability and sense of urgency.

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1 Capa Jobs

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7. Investigation Reports

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Here's how Investigation Reports is used in Senior Associate Quality Assurance jobs:
  • Review and provide feedback comments on investigation reports, protocols/reports/specifications and other quality documents.
  • Maintained QA monthly metrics for lot release, investigation reports, and media batch records.
  • Review, edit and approve investigation reports.
  • Reviewed and approved Investigation and Laboratory Investigation Reports (IRs and LIRs).
  • Review and approve Exception/Investigation and Laboratory Investigation Reports (ERs/IRs and LIRs).

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1 Investigation Reports Jobs

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8. FDA

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high Demand
Here's how FDA is used in Senior Associate Quality Assurance jobs:
  • Assisted with development and implementation of guidelines to ensure regulatory compliance with FDA and other regulatory agencies.
  • Entrusted with high profile and confidential material/information/communications related to clinical trials/results and the FDA.
  • Participate in FDA and other regulatory inspections.
  • Represented SM&R to the Food and Drug Administration (FDA) and other governmental authorities during Regulatory inspections.
  • Served on the audit team for the 2011 FDA inspection, designated a team member for future regulatory inspections.
  • Provided assistance and service to internal customer auditors along with external auditors (FDA, AABB, etc.)
  • Represent PQA area during external and internal audits (FDA, TAKEDA, EMEA, and Brazil).
  • Facilitated inspections by regulatory agencies: FDA, NYSDOH, OSHA, AABB, the European Union.
  • Provided on-site presentation support in Washington, DC for team presenting to FDA.
  • Assisted in preparations for a successful FDA Pre-Approval Inspection (PAI).
  • Contributed to risk assessments and gap analyses following FDA and MHRA guidelines.
  • Performed internal/QS supplier audits and CAPA for compliance to FDA regulations.
  • Participated in FDA and other third party audits, when necessary.
  • Provide QA/QC with appropriate, current FDA/ICH Guidance Documents.
  • Acted as a Scribe during FDA PAI inspection.
  • Assisted in FDA audits and Internal Audits.
  • Provided assistance during FDA inspections.
  • Acted as Team Leader in both inter and intra-departmental projects, validations, and FDA audits.
  • Attended various QA, FDA and cGMP Compliance seminars.
  • Developed, revised and approved SOPs according with GMPs, GLPs and other FDA guidelines.

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3 FDA Jobs

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9. Validation Protocols

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high Demand
Here's how Validation Protocols is used in Senior Associate Quality Assurance jobs:
  • Approve process validation protocols and Media Fill batches.
  • Reviewed validation protocols and reports, product specifications, label requirements for medical devices designs and processes.
  • Authored quality and operational SOPs and validation protocols.

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4 Validation Protocols Jobs

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10. GMP

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high Demand
Here's how GMP is used in Senior Associate Quality Assurance jobs:
  • Developed and coordinated GMP training program for the QC, Manufacturing and Development departments.
  • Participate in audits of Quality Systems and GMP processes and facilities.
  • Bulk DS aseptically removal sampling process GMP documents review.
  • Ensured GMP compliance for raw materials and components disposal.
  • Assisted with GMP internal and external audits.
  • Supported validation of equipment and computerized systems in bringing new manufacturing plant into cGMP compliance.
  • Conducted on-site cGMP qualification audits for international manufacturers of raw materials for pharmaceutical use.
  • Performed internal audits to ensure cGMP compliance within Millennium Pharmaceuticals.
  • Trained employees on training programs (GMP/SOP training for all departments on site) Coordinated data and documentation review and analysis.
  • Manage & provide Quality Assurance support to fast pace multiple cGMP projects.
  • Establish cGMPs to new 3rd party contractors using Corporate Quality Modules.
  • Ensured compliance by reviewing all forms of cGMP documentation.
  • Conducted Internal and customer audits to meet cGMP.
  • Review and approve GMP analytical data for compliance.
  • Perform cGMP yearly employee training.
  • Assist in deviation process &/or CAPA as per appropriate SOP &/or cGMP.
  • Conducted SOPs, on the job and GMP training.
  • Managed and prioritized multiple projects simultaneously with dual reporting structures Monitored Contract Manufacturing Operations ensuring cGMP Compliance
  • Utilized the company's enterprise content management system (Documentum) to maintain cGMP documentation in a secured and controlled manner.
  • Manage and coorinate review and approve of Quality related documents for cGMP activities.

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12 GMP Jobs

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11. Raw Materials

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high Demand
Here's how Raw Materials is used in Senior Associate Quality Assurance jobs:
  • Review laboratory data for analysis of raw materials, intermediate and finish products.
  • Release of raw materials for Manufacturing according to specifications and documentation requirements.
  • Support logistics with processing Raw Materials and Return Authorizations.
  • Audit all documentations and process for Incoming, Raw Materials, Reserve and Warehouse areas.
  • Review and release of all raw materials for manufacturing and packaging.
  • Prepared metrics on raw materials and provided management with monthly reports.
  • Assigned release dispositions to raw materials and finished products.
  • Received and incoming inspection of all raw materials.
  • Review and release of raw materials.
  • Dispositioned raw materials, components and final products.

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12. Oversight

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high Demand
Here's how Oversight is used in Senior Associate Quality Assurance jobs:
  • Provided daily Quality Assurance oversight for sterile radioactive drug and sterile and non-sterile medical device manufacturing activities.
  • Change Control Administrator including oversight of Change Control Database, documentation review and Change Control approval.
  • Participated in the development and implementation the quality oversight program.
  • Provided oversight of Calibration and Preventative Maintenance systems.
  • Provided quality oversight for Manufacturing, Supply Operations, and Quality Control in order to meet production needs and infusions deadlines.
  • Supervised/coordinated daily activities of QAA I/II to ensure site quality oversight and control in all production areas and labs.
  • Handled customer complaints, deviations and investigations, batch records review, release and oversight of product stability.
  • Interact with staff involved Oversight of implementation of data quality assurance procedures across all studies.
  • Maintained Quality oversight of Clinical Trial (phase 2) activities.
  • Provided planning and oversight of meetings of 500+ attendees.
  • Provide continuous compliance oversight of contractors and vendors.
  • Participated on walk through and oversight audit.
  • Assist in QA oversight of analytical technology transfer with contract testing laboratory.

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3 Oversight Jobs

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13. Corrective Action

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high Demand
Here's how Corrective Action is used in Senior Associate Quality Assurance jobs:
  • Reported on weaknesses, ineffective procedures, policy exceptions and discrepancies and recommend appropriate corrective actions.
  • Monitor corrective actions identified during internal QAU, regulatory and sponsor audits.
  • Managed internal and supplier audits and corrective action follow-up.
  • Investigated customer complaints and ensured corrective actions are completed.
  • Coordinated and lead the Internal Audit program of the company, perform audits, prepares audit reports and track corrective actions.
  • Perform internal investigations - Document, Implement and Verify Corrective Actions and Preventive Actions.
  • Performed internal audits and followed up on corrective actions.
  • Reviewed and approved investigations and commitments assuring that the root cause was identified and that corrective actions/preventative actions were appropriate.
  • Generated audit reports and evaluate responses and maintain vendor audit corrective actions Performed training of new audit participants.
  • Reviewed, approved and tracked closure of deviations, non-conformances, OOS and corrective actions.
  • Perform Incoming inspection Review/approve Batch Records, deviation, investigation, Analytical Reports for external manufacturers Create/Revise/Review investigation/deviations and corrective actions.

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14. Data Entry

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high Demand
Here's how Data Entry is used in Senior Associate Quality Assurance jobs:
  • Conduct QA sampling, Data entry in company ERP system.
  • Perform data entry and data research activities.
  • Audited data entry and final submissions for correctness and completion within required timeframes with accuracy for public advertising and distribution.

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15. Product Quality

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Here's how Product Quality is used in Senior Associate Quality Assurance jobs:
  • Provided weekly summary reports of product quality complaints to executive management and project teams.
  • Monitored the outgoing product quality and compiled lot packets with associated release documentation.

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1 Product Quality Jobs

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16. Management System

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Here's how Management System is used in Senior Associate Quality Assurance jobs:
  • Provide support for quality documentation & serve as Electronic Document Management System Power User.
  • Implemented, maintained a laboratory Consumable Inventory Management System (CIMS) to support an aggressive QC Laboratory 24/7 operations.
  • Interacted with IT team globally to assist in SAP improvement and roll-out for Quality Notifications Management System.
  • Maintained hard copy and Learning Management System (LMS) training files for approximately 800 employees.
  • Follow Quality Management System requirements at all times, and helped to maintain Quality System Procedures.
  • Worked as Key Business/Super User for Project Sapphire (SAP) material management systems software.
  • Sample tracking conducted in LIMS (lab info management system).
  • Maintained and assisted with the maintenance of document management systems.
  • Provided support in the training of Compliance Associates and the maintenance of Pilgrim SmartSolve electronic Quality Management Systems.

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17. QC

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Here's how QC is used in Senior Associate Quality Assurance jobs:
  • Evaluate validation procedures, protocols, reports, and raw QC data for accuracy and compliance with corporate and regulatory standards.
  • Coordinated SAP activities (data entry, training, and data reporting) related to each PQC Investigation.
  • Mentored the new joiners about the System, the different Application and HP QC.
  • Review batch records, QC testing records, and all supporting records.
  • Generate qualification protocols, qualification reports and QC COA within QC.
  • Monitor metrology charts for QC lab refrigerators, freezers, and environmental chambers.
  • Ensured proper handling of adverse events reported in conjunction with PQCs.

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18. Document Control

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Here's how Document Control is used in Senior Associate Quality Assurance jobs:
  • Re-designed secure Document Control Room for systematic archival and easy retrieval.
  • Oversee Document Control system for entire organization.
  • Managed Document Control and Training for all GMP related job functions that enabled employees to perform their jobs more efficiently.
  • Maintain Document Control including, SOP Program and GMP Document Retention / Archival Systems.
  • Developed a document control tracking database, and a timeline procedure for the timely release of products.
  • Write and update Standard Operating Procedures (SOPs) and associated forms for proper document control handling.
  • Modified and enhanced Document Control database to provide traceability between working documents and SOP's.
  • Document Control - Issue controlled documents (SOPs/logbooks/etc.)

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1 Document Control Jobs

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19. UAT

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Here's how UAT is used in Senior Associate Quality Assurance jobs:
  • Evaluate documentation and operations according to company procedures and understand basic word processing, presentation and spreadsheet application skills.
  • Implement the defined QA procedures to plan, design, implement, execute, evaluate and report results of software testing.
  • Draft technical reports to investigate consumer complaints based on findings of the batch review and evaluation of product samples.
  • Assure timely initiation, classification, closure and effectiveness evaluation of filling and packaging production deviations and CAPA's.
  • Summarize data using evaluative techniques and statistical analysis and prepares summary report for each product for APQR reports.
  • Evaluate validation activities using industry standards, company policies and federal regulations (21 CFR Part 11).
  • Evaluate retained product samples and remitted consumer complaint samples to determine root cause of the complaint.
  • Handle the tasks of identifying UAT testers and managing resource plan by coordinating with business stakeholders.
  • Perform and support audits for GMP activities to evaluate the compliance with the procedures and practices.
  • Coordinate and participate in triage meeting to evaluate issues during the manufacturing and packaging process.
  • Executed the test cases, gathered and evaluated results and generated test summary reports.
  • Participate and evaluates changes on procedures, methods and inspection forms.
  • Perform problem solving in different situations at the Finished Packaging process.
  • Evaluate plan, and implement solutions for process improvement opportunities.
  • Evaluate complaint data for trends.
  • Interview and evaluate QA candidates.
  • Worked extensively on web-based testing and involved in UAT environment, pre-production environment and production environment.
  • Managed and evaluated the Change Control and Document Change Request approval process for both pre- and post-implementation.
  • Forward all completed reports and evaluations to the appropriate customer(s) within established timeframes.
  • Evaluated and reviewed cGMP and SOPs with quality assurance staff ensured effectiveness of cGMP Practices and SOP's.

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20. Process Improvement

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Here's how Process Improvement is used in Senior Associate Quality Assurance jobs:
  • Direct process improvement activities to complete validation activities for the development of the clinical data collection systems and product acceptance.
  • Participated in Operations and QA departmental meetings for review of quality concerns and help identify areas for process improvement.
  • Participated on process improvements projects and/or teams pertaining to maintaining to advance quality improvements efforts philosophically and culturally.
  • Contributed to the Team's overall effectiveness by providing assistance to leadership on process improvement.
  • Focused on problem solving by implementing industry best practices and ensured continuous process improvement.
  • Implemented Engineering focal point for all prototype issues with Material Management as process improvement.
  • Help to provide recommendations for process improvements and/or procedures.
  • Identify and support process improvement opportunities.
  • Led IVRS process improvement initiatives in the department.
  • Lead participant in QA Process Improvement initiatives.
  • Identified quality issues, opportunities for standardization and/or process improvements and communicated them in a timely manner to appropriate management.
  • Served as trainer for new quality staff and newly released procedures Participated and chaired regional and divisional process improvement workgroups

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21. Business Requirements

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Here's how Business Requirements is used in Senior Associate Quality Assurance jobs:
  • Translate business requirements and functional specifications into test plans and test scripts.

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22. Trackwise

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Here's how Trackwise is used in Senior Associate Quality Assurance jobs:
  • Assist in product complaint investigations by performing visual exams on returned and retained samples and entering the results into TrackWise.
  • Tracked and trended investigations in SAP-CAPA / TrackWise (QTS) investigation systems.
  • Trained colleagues in the use of TrackWise investigation system.
  • Work in multiple Database SAP, Trackwise and LIMS.

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1 Trackwise Jobs

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23. Lims

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Here's how Lims is used in Senior Associate Quality Assurance jobs:
  • Realize special sampling, get results, initiate chain of custody and perform other approvals in LIMS system.
  • Utilize LIMS and Oracle to review, approve and release of raw materials and components.
  • Receive, handle, and deliver process samples and initiate chain of custody with SM-LIMS.
  • Coordinated and tracked of sample submissions and results at LIMS and Eagle LIMS.
  • Achieved implementation of required raw material builds for Rouses Point in LabWare LIMS from SQL-LIMS 1 month ahead of scheduled timeline.
  • Represented QA on various cross-functional project teams, such as Amgen's initial implementation of the SM-LIMS system.
  • Achieved team success in streamlining site configurable object processes, SOPs, and forms for LabWare LIMS.

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24. Product Release

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Here's how Product Release is used in Senior Associate Quality Assurance jobs:
  • Create validation test scripts, and engage in the review/approval of batch records and product release data.
  • Follow up with the Change Controls pertaining to the product release.
  • Coordinate and approve product release to the clients.
  • Initiated and Developed effective internal and contractor Product Release procedures (SOPs) which expedited the release of clinical product.
  • Liaised with customers and departments, communicating product release timelines, metrics, and support for regulatory filings.

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25. SQL

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Here's how SQL is used in Senior Associate Quality Assurance jobs:
  • Create SQL queries to validate data in the SQL Server database for positive and negative scenarios.
  • Produce a monthly Portfolio Analysis Report using on-demand SQL Queries and other tools.
  • Developed SQL queries in Toad and DB Artisan to achieve the data transformations.
  • Designed SQL queries for execution process to be implemented in Toad tool.
  • Validated databases (MSSQL) in conjunction with Applications under Test.
  • Created and executed SQL queries in ORACLE and MS SQL server.
  • Soap Request Generator, SQL Work Sheet.
  • Created various PL/SQL stored procedures for dropping and recreating indexes on target tables.

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26. GLP

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Here's how GLP is used in Senior Associate Quality Assurance jobs:
  • Assist in GLP Facility, testing site and study audits as required.
  • Maintain associated QA records pertaining to all GLP clinical and non-clinical studies.
  • Review, maintain, and approve GLP and GMP documentation.
  • Conduct vendor qualification and internal GMP/GLP audits.
  • Complied with cGMP, GLP and FDA regulations for testing, approval, documentation and routine Lab.
  • Review laboratory and manufacturing specifications, equipment qualifications for accuracy and compliance with cGMP, GLP and company SOPs.
  • Monitored pre-clinical GLP studies at CRO and intra-departmental sites to ensure protocol/regulatory compliance (Covance).

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27. ISO

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Here's how ISO is used in Senior Associate Quality Assurance jobs:
  • Coordinated travel, investigator/physician meetings, physical therapy training for clinical studies, and advisory board meetings.
  • Facilitate quality calibrations with QA Team and Supervisors / Operations Managers.
  • Manage junior quality assurance associates as primary supervisor.
  • Appointed as liaison between Quality Labs and Manufacturing in the tracking of water, CIP/Release, and In-process samples.
  • Assisted in project transfers for Contract Manufacture Operations acting as a liaison between quality and contract manufacture group.
  • Designated Controlled Drug Substance (CDS) liaison, managed all incoming and outgoing CDS materials.
  • Serve as back-up for Supervisor, Documentation Management and provide senior level support, as needed.
  • Perform daily liaison activities between customer service, the corporate quality group and contract distribution facilities.
  • Participate in FDA, ISO, UL, Internal and third party regulatory on-site audits.
  • Gained expertise in writing Work Instructions and Job Aids by following ISO format.
  • Provide technical guidance and support for all Quality Management Systems initiatives and FDA regulations and ISO Standards (e.g.
  • Qualified and maintained ISO Class 7 cleanroom space.
  • Assisted with the start up of Sydcor, teaching an offsite facility the value of internal/external customers and ISO compliance.
  • Serve as liaison between Endo and DCs for all quality related matters.

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28. CFR

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29. QTP

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Here's how QTP is used in Senior Associate Quality Assurance jobs:
  • Executed the regression test cases along with testing new enhancements by using QTP and analyzed results.
  • Created automated scripts using Quick Test Pro (QTP).
  • Performed Data Driven Tests and Action Based recording using QTP.
  • Worked on creating smoke test scripts using QTP.
  • Involved in Descriptive Programming using QTP.
  • Customized or Parameterize Scripts that were previously recorded in QTP as well as new scripts.

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30. Drug Products

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Here's how Drug Products is used in Senior Associate Quality Assurance jobs:
  • Provide support to site investigations Generate and/or collect data related to pharmaceutical drug products for APQR reports.

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31. Quality Standards

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Here's how Quality Standards is used in Senior Associate Quality Assurance jobs:
  • Support new product launches through process, packaging and cleaning validation, protocols, reports and quality standards.
  • Manage KYC QA activities for new and existing businesses and multiple remediation efforts concurrently within designated timeframes and quality standards.
  • Developed and implemented effective corrective and preventative actions (CAPAs) to improve and maintain quality standards.

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32. Regulatory Inspections

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Here's how Regulatory Inspections is used in Senior Associate Quality Assurance jobs:
  • Contributed during the regulatory inspections by providing necessary documentation and assistance.
  • Supported regulatory inspections which included FDA, AABB, FACT, ASHI.

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33. User Acceptance

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Here's how User Acceptance is used in Senior Associate Quality Assurance jobs:
  • Developed and led User Acceptance Testing sessions and recorded user feedback for project backlog estimations and planning.
  • Conducted systems User Acceptance Testing (UAT).

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34. GUI

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Here's how GUI is used in Senior Associate Quality Assurance jobs:
  • Coordinated automated test plan creation and execution using standard QA methodology guidelines.
  • Provide quality oversight and guidance to pharmaceutical manufacturing and packaging operations.
  • Provide Quality Assurance guidance to Quality Assurance personnel.
  • Provided technical/quality guidance to other groups.
  • Provide guidance in determining the impact, corrective and preventative actions and product disposition arising from excursions from procedures and processes.
  • Composed new and updated existing job aid guidance documents, outlining new processes and procedures to follow in the LMS upgrade.
  • Provided team support to R&D and manufacturing projects as well as overall compliance guidance to the company.
  • Performed 100% inspection of packaging material to determine acceptance for use per all Quality and Regulatory department guidelines.
  • Performed Sanity testing, Security testing, black box, white box testing, web testing and GUI testing.
  • Performed Integration, functional, GUI testing and User Acceptance Testing assistance as needed, with business partners.
  • Maintained current knowledge base of existing and emerging regulations, standards, or guidance documents.
  • Provided guidance to entering level QA staff in the accomplishment of QA operational activities.
  • Guided and supported end-users through the testing effort ensuring proper focus and schedule adherence.
  • Provided guidance to junior members of QA and departmental investigators.
  • Provided guidance to Principal Investigators in Root Cause Analysis and CAPA determination to mitigate reoccurrence of exceptions.
  • Stay up-to-date with relevant guildlines and assist with regularly scheduled internal training.
  • Provide daily guidance and support to Production staff in regards to compliance with Standard Operating Procedures and Work Instructions.
  • Performed GUI, Ad-hoc, Smoke, Database Testing, functional and regression Testing.
  • Provide guidance and quality assurance support to cGMP personnel for the compliance.
  • Worked on Claims Transformation project to replace legacy application with Guidewire products such as Claim Center.

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35. R

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Here's how R is used in Senior Associate Quality Assurance jobs:
  • Approve disposition of production materials for manufacturing processes, and approve the release of final products based on documentation and specifications.
  • Completed written investigations and document reports for regulatory commissions and client guaranteeing the safe, pure effectiveness of product.
  • Manage vendor/service provider audit and qualification program, using Site visits and investigation of 3rd party Certifications.
  • Charted / graphed pharmaceutical standards and deviations with relation to regulatory investigations resulting in 100% compliance.
  • Conducted canine and non-human primate electrocardiogram and blood pressure acquisition via PONEMAH data acquisition system.
  • Exercised strong leadership talents in delegating personnel assignments related to use of PONEMAH acquisition systems.
  • Verify that only approved pesticides/insecticides are used.
  • Train and mentor 3 Quality Assurance staff and temporary contract employees to ensure they understand company policies and values.
  • Manage the Pest Control program for the three facilities and am the contact person for pest control problems.
  • Reported To: Director, Quality Assurance Managed a team of testers responsible for validation of Y2K changes.
  • Full understanding of all Quality Management Elements, maintaining QMS to 'audit ready' level.
  • Maintain pest control maps that have locations of the bait/trap locations.
  • Facilitated site closings in Ann Arbor and Kalamazoo Michigan.
  • Lead External (supplier audits) as required.
  • Work with operations to resolve basic compliance discrepancies.
  • Conduct reviews of the Pest Control bi-monthly reports.
  • Researched and investigated quality assurance discrepancies Ensured commercial pharmaceutical labels, insert and packaging materials met regulatory standards proofreading all materials.
  • Recognized as department expert in troubleshooting PONEMAH technology and qualified to train and recertify users in system use.
  • Proof reading against approved master copy, quantity verification, inspecting labels on Arpeco.
  • Created and distributed SOPs for new products which ensured proper production operations.

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36. SME

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low Demand
Here's how SME is used in Senior Associate Quality Assurance jobs:
  • Provided immediate compliance assessment and path forward at deviation occurrence to minimizing negative impact to product and process.
  • Job Hazard Assessment: I authored a Job Hazard Assessment for our team in support of PQA on the floor implementation.
  • Developed laboratory analysis and performed as SME in Dry Weight Determination analysis using CEM Smart 5 equipment, among others.
  • Perform Batch Record assessment on industry for compliance with Corporate Policies and Federal Regulations, GMP's and GDP's.
  • Acted as the lead QA contact for our department as well as an SME for all matters related to quality.
  • Author protocols, provide impact assessment on Incoming Materials, and process team assessments of vendor notifications.
  • Served as Quality Assurance representative in Quality Risk Assessments, implementing new products and processes.
  • Authored and reviewed responses to FDA observations, technical assessments and Standard Operating Procedures.
  • Review impact assessments and approve of change controls for all changes related to GMP.
  • Performed an assessment to improve the deviation and CAPA system of the company.
  • Provide SME Support and Team mentoring * Defect Management and Bug regression.
  • Provide ongoing assessment, ideas and assistance in enhancing quality systems.
  • Coordinated the Safety and Health assessment project for the company.
  • Risk Assessment Leader for process improvements/changes using the FMEA method.
  • Reviewed and provided impact assessment for Change Controls associated with laboratory equipment changes, reviewed/ revised both departmental and interdepartmental SOPs.
  • Perform assessment of material risk, compendia requirements, and associated investigations and/or supplier changes pertaining to restricted released material batches.
  • Complete vulnerability assessment using IBM Rational Appscan.
  • Implemented quality assessments to eliminate shelf expiration and deliver a safe, potent and effective product, increasing company revenue.
  • Project Details: 1 Brabeion Compliance Manager: Real Time Monitoring and Control Assessment.
  • Author and review technical assessments and Standard Operating Procedures (SOPs).

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37. Sharepoint

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Here's how Sharepoint is used in Senior Associate Quality Assurance jobs:
  • Maintained controlled documents posted on Quality Assurance SharePoint (shared electronic database).
  • Created and maintained electronic audit request form and departmental SharePoint site.
  • Used SharePoint Web Based Portal to manage the project related documents and QA WIKI.
  • Administered Shire's PQR SharePoint site.
  • Validated the CAML queries in the SharePoint workflows.

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38. API

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Here's how API is used in Senior Associate Quality Assurance jobs:
  • Lead approvals and revisions to Quality Agreements for all CMOs / GMP Labs / CROs & API Suppliers.

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39. Computer System

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Here's how Computer System is used in Senior Associate Quality Assurance jobs:
  • Conducted compliance audits on regulated computer systems that collect clinical and laboratory data for regulatory submissions.
  • Approved results, added or deleted orders in SAP and LACES computer systems.
  • Work with various computer systems: Trackwise, SAP, Access databases.

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40. Analytical Methods

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Here's how Analytical Methods is used in Senior Associate Quality Assurance jobs:
  • Review and approve analytical methods and method validation and method transfer documentation required for clinical study through commercialization.
  • Review and approve SOPs, MBRs, Analytical Methods, Specs, and other quality documents.

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41. OOS

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42. Product Complaints

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Here's how Product Complaints is used in Senior Associate Quality Assurance jobs:
  • Eliminated backlog of product complaints by conducting investigations and implementing corrective and preventative actions.
  • Provide support for Investigations associated with Product Failures and Product Complaints.

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43. Customer Complaints

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Here's how Customer Complaints is used in Senior Associate Quality Assurance jobs:
  • Created procedure for handling customer complaints and maintained appropriate logbooks.
  • Analyzed and responded to written customer complaints.

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44. Gcp

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Here's how Gcp is used in Senior Associate Quality Assurance jobs:
  • Interact with the clinical study teams to service as a point of contact for quality assurance and GCP compliance.
  • Develop and implement use of auditing tools and GCP training materials to present at investigator meetings.
  • Managed other GCP auditing, Drug Safety and IRB/EC compliance activities.
  • Audited the compliance with the principles of GCP.
  • Conduct GCP and cGMP audits (Canada, US, EU) reviewed trend analysis and suggested corrective actions.
  • Attend mandatory and on-going training e.g., GCP, clinical trials, IRB training; and conduct GCP presentations.
  • Assisted in the collection and dissemination of relevant/requested GCP information and assisted in providing training to staff.
  • Performed QA audits of CROs, Labs and other Vendors worldwide for GCP and PV compliance.

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45. Management Review

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Here's how Management Review is used in Senior Associate Quality Assurance jobs:
  • Identified deficiencies, documented issues and provided gap training recommendations for management review to correct and prevent future mistakes.
  • Run reports and trend data for change control documents in order to support management review.
  • Track and trend deviations, non-conformances, corrective actions, OOS, change controls and investigations in support of management review.

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46. Material Review

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Here's how Material Review is used in Senior Associate Quality Assurance jobs:
  • Participate in Material Review Board meeting as Quality Assurance representative.
  • Coordinate and Lead MRB(Material Review Board) meetings.
  • Present monthly update at the Material Review Board meeting.
  • Attend and participate on Material Review Board activities (e.g.

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47. Regulatory Documents

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48. Analytical Data

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Here's how Analytical Data is used in Senior Associate Quality Assurance jobs:
  • Review executed non-clinical production records and analytical data, assure compliance with procedures.

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49. CMC

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Here's how CMC is used in Senior Associate Quality Assurance jobs:
  • Verify that the accuracy of all project-related CMC information for regulatory filings through various phases of clinical development.
  • Support Regulatory affairs department by providing CMC documents required for submission and in deficiency response to agencies.
  • Perform quality review and data verification of over 300 CMC documents in preparation for regulatory submission.
  • Assisted in the preparation of regulatory submission (IND, CMC, and NDA).
  • Perform thorough manual testing of the CMC system.
  • Audited CMC data for IND/NDA Submissions.
  • Tested CMC- Content Management Console, a browser-based application that makes use of JavaScript.

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50. EBR

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low Demand
Here's how EBR is used in Senior Associate Quality Assurance jobs:
  • Perform initial review of manufacturing procedures, batch records/ EBR's (Electronic Batch Records), MP's and forms.
  • Verify and approved any changes during the inspection and sampling of materials process on EBR system.
  • Review and approve product MP and electronic batch record (EBR) Review and approve Standard Operation Procedures (SOP).

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Senior Associate Quality Assurance Jobs

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20 Most Common Skills For A Senior Associate Quality Assurance

Test Cases

10.9%

QA

10.6%

Batch Records

9.5%

Ensure Compliance

9.0%

Audit Procedures

6.8%

Capa

6.3%

Investigation Reports

5.6%

FDA

5.4%

Validation Protocols

4.9%

GMP

4.6%

Raw Materials

4.1%

Oversight

3.3%

Corrective Action

3.3%

Data Entry

3.2%

Product Quality

3.0%

Management System

2.3%

QC

2.2%

Document Control

1.6%

UAT

1.6%

Process Improvement

1.6%
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Typical Skill-Sets Required For A Senior Associate Quality Assurance

Rank Skill
1 Test Cases 8.5%
2 QA 8.2%
3 Batch Records 7.4%
4 Ensure Compliance 7.0%
5 Audit Procedures 5.3%
6 Capa 4.9%
7 Investigation Reports 4.4%
8 FDA 4.2%
9 Validation Protocols 3.8%
10 GMP 3.6%
11 Raw Materials 3.2%
12 Oversight 2.6%
13 Corrective Action 2.6%
14 Data Entry 2.5%
15 Product Quality 2.3%
16 Management System 1.8%
17 QC 1.7%
18 Document Control 1.2%
19 UAT 1.2%
20 Process Improvement 1.2%
21 Business Requirements 1.2%
22 Trackwise 1.1%
23 Lims 1.1%
24 Product Release 1.1%
25 SQL 1.0%
26 GLP 1.0%
27 ISO 0.9%
28 CFR 0.9%
29 QTP 0.8%
30 Drug Products 0.8%
31 Quality Standards 0.8%
32 Regulatory Inspections 0.7%
33 User Acceptance 0.7%
34 GUI 0.7%
35 R 0.7%
36 SME 0.6%
37 Sharepoint 0.6%
38 API 0.6%
39 Computer System 0.6%
40 Analytical Methods 0.6%
41 OOS 0.6%
42 Product Complaints 0.6%
43 Customer Complaints 0.6%
44 Gcp 0.5%
45 Management Review 0.5%
46 Material Review 0.5%
47 Regulatory Documents 0.5%
48 Analytical Data 0.5%
49 CMC 0.5%
50 EBR 0.5%
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11,302 Senior Associate Quality Assurance Jobs

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