Analyst - Compliance (Temporary Assignment)
About The Position
This role involves conducting special audits to confirm adherence to specifications, procedures, and regulatory compliance. The position supports specific tasks and functions within the company’s Quality System areas. The Analyst will perform lot document spot screenings, routine monitoring audits (in process only), and generate NCRs for raw materials non-conforming materials. They will also initiate Non-Conformance resolution and assure compliance with laws and regulations. Additionally, the role assists in defining tactics for Quality First Pass, DPM & CPM Metric, quality documentation approval, quality awareness, and ensuring completeness of quality investigations and CAPA’s. The Analyst will evaluate quality issues reports, gather data for quality issue investigations, identify and implement corrective/preventive actions, and prepare rework protocols or memos for NCRs. They will also review/approve NCRs investigations and disposition, evaluate and investigate NCRS, monitor and measure quality KPI’s, keep BU’s aware of actual quality KPI’s, and develop actions to improve quality KPI’s. The role involves developing supporting documentation for QI, providing training for QI, providing support for the QI start-up, and completion of NCR. The Analyst actively participates in completing reports for CAPA, evaluating NCR-raw materials actions effectiveness, approving NCR, Non-Conformance WIP Management, investigating Quality Feedback, monitoring incidents and first acceptance data, developing procedures for QI, performing quality compliance inspections as per applicable TP’s, dry process batch release, and quality feedbacks. The position requires compliance with the Quality System Regulation (QSR), executing job responsibilities as established in Standard Operating Procedures (SOPs), following documentation procedures, and completing required training. Safety and Occupational Health responsibilities include complying with policies and procedures, the Hazardous Communication program, immediately notifying of accidents or incidents, and complying with personal protective equipment usage. Travel may be required.
Requirements
- Knowledge of GMP’s/QSR
- Excellent oral/written communication skills in both English and Spanish languages
- Service oriented
- Ability to coordinate, evaluate and inspect product
- Computer literacy in MS Word, Excel, and Power Point
- Excellent interpersonal skills
- Highly motivated, self-starter, and responsible person
- Five years or more experience in a medical device/pharmaceutical industry in a similar position
- High analytical capacity and level of professionalism and judgment to resolve problems
Responsibilities
- Performing lot document spot screenings
- Performing routine monitoring audits (in process only)
- Generating NCR for raw materials non-conforming materials
- Initiating Non-Conformance resolution
- Assuring compliance with laws and regulations
- Defining tactics for Quality First Pass, DPM & CPM Metric (once a year)
- Quality documentation approval
- Quality awareness
- Ensuring completeness of quality investigations and CAPA’s
- Evaluating quality issues reports at Manufacturing and QA Final
- Investigation (data gathering of quality issue)
- Identifying and implementing corrective/preventive actions
- Preparing rework protocols or memos for NCRs
- Reviewing/approving NCRs investigations and disposition
- Evaluating and investigating NCRS
- Monitoring and measuring quality KPI’s
- Keeping BU’s aware of actual quality KPI’s
- Developing actions to improve quality KPI’s
- Developing supporting documentation for QI
- Providing Training for QI
- Providing support for the QI start-p
- Completion of NCR
- Completing reports for CAPA
- Evaluating NCR-raw materials actions effectiveness
- Approving NCR
- Non-Conformance WIP Management
- Investigating Quality Feedback
- Monitoring incidents and first acceptance data
- Developing procedures for QI
- Performing quality compliance inspections as per applicable TP’s
- Dry process batch release
- Quality feedbacks
- Complies with the Quality System Regulation (QSR).
- Executes job responsibilities as established in the Standard Operating Procedures (SOP).
- Follows the documentation procedures.
- Completes training for the qualification and certification, as required, to execute the job.
- Complies with Safety and Occupational Health Policy and procedures.
- Complies with Hazardous Communication program.
- Notifies immediately all accidents or incidents occurred in work area.
- Complies with the usage, inspection and maintenance of the personal protective equipment required, if applicable.
Stand Out From the Crowd
Upload your resume and get instant feedback on how well it matches this job.
What This Job Offers
Career Level
Mid Level
