- Maintain full compliance of critical systems area, qualifications and calibrations of stem sterilizers with full compliance of cGMPs and other internal and external regulations requirements.
- Approves and assures that all reports related to calibrations, sterilizers, critical systems and environmental comply with procedures, policies and regulations.
- Review and approve nonconformance investigations as quality representative.
- Conduct nonconformance investigations for critical systems area as necessary.
- Fill out, analyzes and understand all necessary documentation to comply with all specifications, SOP's, protocols and instructions.
- Evaluate or initiate Change Controls as required.
- Perform quality oversight to all Plant Critical Systems such as: Distilled Water, Compressed Air, Nitrogen Environment, Sterilization, calibrations, etc. to assure compliance with Local and Federal agencies.
- Generate quality metric or reports for areas of responsibility.
- Perform quality oversight to ensure compliance in area of responsibility.
- Review specifications, changes, corporate policies changes, to assure that Critical Systems area complies with requirements.
- Work on quality improvement projects to enable flexibility and simplicity.
- Must keep the work area in the cleanest and order conditions, to comply with the 6s and lean concepts.
- Can work individually and as a team member/leader.
- Should be able to coordinate meetings and presentations.
- Should be able to work under minimum supervision.
- Should be able to work with many projects and handle multiple tasks at the same time.
- Must coordinate all the necessary activities to perform protocols, should be able to solve unexpected situations to complete protocols and comply with all internal and external standards.
- Should be able to comply with the established projects goals and schedule milestones.
- Must be able to communicate effectively at any plant level.
- When required, participates inside the inspection room during Regulatory Inspections
- Must perform any work necessary to avoid the delay in the release of the product.
- Performs weekly, monthly, and annual reports as required by management, policies, and procedures.
- Keep supervisor informed of areas activities and issues.
- Willing to travel.
- Other activities as required by supervisor.
- EDUCATION and/or EXPERIENCE
- LANGUAGE SKILLS
- MATHEMATICAL SKILLS
- REASONING ABILITY
- CERTIFICATES, LICENSES, REGISTRATIONS, EXAMS
- COMPANY REGULATORY COMPLIANCE
- PHYSICAL DEMANDS
- WORK ENVIRONMENT
- SAFETY EQUIPMENT and/or EQUIPMENT
Quality Associate III - Jayuya, Puerto Rico - Baxter
Descripción
This is where you save and sustain lives
At Baxter, we are deeply connected by our mission. No matter your role at Baxter, your work makes a positive impact on people around the world. You'll feel a sense of purpose throughout the organization, as we know our work improves outcomes for millions of patients.
Baxter's products and therapies are found in almost every hospital worldwide, in clinics and in the home. For over 85 years, we have pioneered significant medical innovations that transform healthcare.
Together, we create a place where we are happy, successful and inspire each other. This is where you can do your best work.
Join us at the intersection of saving and sustaining lives— where your purpose accelerates our mission.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
QUALIFICATIONS
Bachelor's degree in Engineering or Sciences (B. S.); three to five year of previous experience in Critical Systems including Utilities. Computer knowledge (Word, Power Point, Excel, Trackwise). Knowledge in regulatory standards. Master Degree is preferred.
Ability to read and interpret documents such as safety rules, operating and maintenance instructions, and procedure manuals. Ability to write routine reports and correspondence. Ability to speak effectively in front of groups of employees, supervisors, internal and external auditors. Fluently in English and Spanish languages (written and oral). Ability to communicate, read, write and understand English/Spanish languages.
Ability to add, subtracts, multiply, and divide in all units of measure, using whole numbers, common fractions, and decimals. Ability to compute rate, ratio, and percent and to draw and interpret bar graphs.
cGMPs Training, Safety Trainings, certificates, licenses, exams and registrations that the immediate supervisor refers .
Observes and promotes company security, industrial hygiene, cGMP's, procedures and other security measures already established by the company; should inform any violation. Able to follow all GMP requirements while conducting the assigned duties and completing official documents.
While performing the duties of this job, the employee is regularly required to sit. The employee is occasionally required to stand; walk; use hands to finger, handle, or feel; reach with hands and arms; and talk or hear. The employee must occasionally lift and/or move up to 10 pounds. Specific vision abilities required by this job include close vision.
While performing the duties of this job, the employee can be exposed to extreme cold. The noise level in the work environment is usually moderate.
DISCLAIMER STATEMENT:
The above statement are intended to describe the general nature and level or work being performed by people assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of personnel so classified.