Analyst - Compliance (Temporary Assignment)

CooperVision; Juana Díaz (PR); On-site; USD 55,000 - 85,000; Full time

Job summary

CooperVision is seeking a Quality Auditor to conduct audits ensuring adherence to specifications, procedures, and regulatory compliance. You will support Quality System activities, manage NCRs, and help drive CAPA and QI initiatives in a fast-paced environment.

The ideal candidate holds a Bachelor's in a related field or equivalent document control experience, with strong English/Spanish communication and proficiency in Word/Excel/PowerPoint, and willingness to travel as needed.

Qualifications

• Knowledge of GMP’s/QSR and regulatory requirements.
• Excellent oral and written communication in English and Spanish.
• Service oriented with ability to coordinate, evaluate and inspect product.
• Computer literacy in MS Word, Excel, and PowerPoint.
• High analytical capacity and professional judgment.

Responsibilities

• Perform lot document spot screenings and routine monitoring audits.
• Generate NCRs for non-conforming materials and initiate resolution.
• Ensure compliance with laws and regulations and quality KPIs.
• Assist in defining tactics for quality metrics and approve quality documents.
• Provide training and support for QI activities and CAPA completion.
• Participate in CAPA reports and investigations, and monitor NCR actions.
• Possibility of travel as required by the role.

Skills

GMP/QSR knowledge

English/Spanish

Coordination

Product inspection

MS Word

Excel

PowerPoint

Interpersonal skills

Self-motivated

Education

Bachelor's degree in business or science

Document control experience

Tools

MS Word

Excel

PowerPoint

Job description

JOB DESCRIPTION

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

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