Conducts special audits to confirm adherence to specifications, procedures and regulatory compliance.
Supports specific tasks and functions within the company’s Quality System areas. Conducts special audits to confirm adherence to specifications, procedures and regulatory compliance.
Responsibilities
Essential Functions & Accountabilities:
Accountable for:
- 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
Assist in:
- 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
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
- Quality feedbacks
Quality System Responsibilities
- 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.
Safety & Occupational Health Responsibilities
- 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.
Travel:
- Could be required to travel
Qualifications
Knowledge, Skills and Abilities:
- 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
Work Environment:
- Generally works in a closed environment, in office conditions, with loud level of noise and controllable changes of temperature
- Needs to stand, walk, and may be seated for a long period of time
- Uses hands to feel, handle, and reach
- Performs light physical effort with little exposure to adverse conditions
- Could be required to travel
- Works with a personal computer and programs to prepare documents or reports
- Applies communication skills (advanced reading, writing, and technical skills) and mathematical concepts knowledge to perform work and coordinate with others
Needs to have high analytical capacity and level of professionalism and judgment to resolve problems
We are committed to equal employment opportunity regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, gender, gender identity or expression, or veteran status. We are proud to be an equal opportunity workplace.”
Qualifications
Qualifications
Knowledge, Skills and Abilities:
- 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
Work Environment:
- Generally works in a closed environment, in office conditions, with loud level of noise and controllable changes of temperature
- Needs to stand, walk, and may be seated for a long period of time
- Uses hands to feel, handle, and reach
- Performs light physical effort with little exposure to adverse conditions
- Could be required to travel
- Works with a personal computer and programs to prepare documents or reports
- Applies communication skills (advanced reading, writing, and technical skills) and mathematical concepts knowledge to perform work and coordinate with others
- Needs to have high analytical capacity and level of professionalism and judgment to resolve problems
Experience:
- Five years or more experience in a medical device/pharmaceutical industry in a similar position
Education:
- Bachelor's degree in business administration or science or related experience in a document control environment
