11 Medical Assistants jobs in Fajardo

**The Opportunity**
Responsible for the evaluation of donor suitability for automated pheresis procedures. Administration and supervision of approved immunizations. Provides limited emergency medical care to donors and staff, including the administration of medication or treatments in accordance with licensure or certification. Responsible for the efficient and effective collection of plasma from donors by performing venipuncture, monitoring the pheresis process. Perform health screening procedures.
You will report to the Center Manager for day-to-day activities, and for medical related questions, to Center Medical Director.
**The Role**
+ Conducts confidential and effective donor interviews to obtain necessary information regarding suitability to donate plasma. Performs medical history reviews and health assessments on donors. Assesses results of donor screening and laboratory tests to determine initial and continuing donor suitability. Assess signs and symptoms a donor may exhibit that may result in the inability to continue donating.
+ In conjunction with the Center Medical Director and/or Center Physician, responds to medically related questions from staff including donor suitability and provides information to staff on medically related issues.
+ Notifies and counsels donors regarding reactive test results. Refers donors to community facilities for follow-up and counseling. Reviews test results and determines continued donor suitability. Maintains knowledge of and apply all rules regarding four-month approvals and grace periods.
+ Explains Informed Consent to donors, as required by SOP. This includes explanation of procedures, hazards, and potential adverse events; explanation of immunization schedules, dose, and antibody response; providing clear opportunity for donor to refuse participation; obtaining signature and date certifying informed consent.
+ Handles medical emergencies at the Center by providing routine care as outlined in Standard Operating Procedures (SOPs); elevates situations to Center Physician or local medical service providers as required. Assures emergency kits supplies are present and in-date.
+ Manages employee hepatitis B immunization program, including administration of immunizations in accordance with licensure or certification. Understands the policies and procedures associated with hyper immune programs at the center, where applicable, and oversees donor immunization programs. Reviews antibody titer results as required. Maintains awareness of appropriate immunization schedule for each antigen.
+ In compliance with SOPs, performs all aspects of the pheresis procedure and plasma collection process, including donor set-up, venipuncture, donor monitoring, and donor disconnect. Collects arm samples or whole blood samples from donors for testing.
+ Required to perform equipment calibrations and verify that maintenance has been performed as outlined in the SOPs. Respond to and resolve complex equipment alarms or donor issues. Uses Personal Digital Assistant (PDA) to record incidents that occur during the pheresis process, such as machine alerts and alarms, volume variances and donor adverse events.
+ Conducts donors screening process. The screening procedures includes but are not limited to assessing the self-administered health history questions, answering basic medical questions associated with the donation process and performing health screening procedures such as blood pressure, pulse, weight, and temperature. Performs finger stick to obtain capillary tube sample. Completes hematocrit and total protein testing. Accurately records donor data in the electronic donor information management system.
+ Maintains clean efficient work environment and stocks operating supplies and forms as needed. Follows all Health Safety & Environmental and Occupational Safety and Health Administration (OSHA) policies and procedures. Promotes safety in all actions. May conduct routine audits of these internal procedures and documentation.
+ Maintains confidentiality of all personnel, donor, and center information.
+ Cross trained in other areas to meet the needs of the business.
+ Perform other job-related duties as assigned.
**Your skills and experience**
**Education**
+ Active licensure from a nursing, physician assistant, chiropractic, naturopathic training program or medical school required OR
+ Completion of a foreign allopathic or osteopathic medical school and only if also currently licensed as a physician.
**Experience**
+ Minimum of one (1) year experience in a health care environment or one year of clinical experience from a vocational or nursing institution.
+ Experience in a plasma or whole blood collection center or another regulated environment preferred.
+ Ability to make and analyze a physical assessment of heart, lung sounds, signs of drug use, etc.
+ Ability to instruct donors, staff, and community regarding the benefit of plasma donation programs.
**Additional Comments**
+ Bilingual skills may be required, at the discretion of the organization, to meet the needs of the business.
**Working Conditions**
(physical & mental requirements)
+ Ability to make decisions, which have moderate impact on immediate work unit.
+ Ability to understand, remember and apply oral and/or written instructions
+ Must be able to see and speak with customers and observe equipment operation
+ Occasionally perform tasks while standing and walking up to 100% of time
+ Examine and assess the skin and other abnormalities through sight, touch and smell
+ Reach, bend, kneel and have high level of manual dexterity
+ Occasionally be required to lift and carry up to 25 pounds
+ Fast paced environment with frequent interruptions
+ Frequently exposed to hazardous chemicals, extreme temperatures and to blood borne pathogens
+ Required to wear Personal Protective Equipment while performing specific tasks or in certain areas
+ Required to work overtime and extended hours to support center operational needs
**Our Benefits**
We encourage you to make your well-being a priority. It's important and so are you. Learn more about how we care ( at CSL.
**About CSL**
CSL is a leading global biotechnology company with a dynamic portfolio of life-saving medicines, including those that treat haemophilia and immune deficiencies, as well as vaccines to prevent influenza. Since our start in 1916, we have been driven by our promise to save lives through innovation. Learn more about CSL ( .
**We want CSL to reflect the world around us**
At CSL, Inclusion and Belonging is at the core of our mission and who we are. It fuels our innovation day in and day out. By celebrating our differences and creating a culture of curiosity and empathy, we are able to better understand and connect with our patients and donors, foster strong relationships with our stakeholders, and sustain a diverse workforce that will move our company and industry into the future. Learn more Inclusion and Belonging | CSL ( work that matters at CSL!**
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CSL makes all employment decisions without regard to race, color, religion, national origin, ancestry, age, sex, gender, pregnancy, disability, marital status, sexual orientation, gender identity, genetic information, military status, protected veteran status (specifically status as a disabled veteran, recently separated veteran, armed forces service medal veteran, or active duty wartime or campaign badge veteran) or other classification protected by applicable US federal, state or local law. CSL complies with all applicable employment laws, including but not limited to Title VII of the Civil Rights Act of 1964, the Americans with Disabilities Act, the Fair Labor Standards Act, and the Immigration Reform and Control Act.

Job Description

Job Description

Validation & Engineering Group, Inc. (V&EG) is a leading services supplier who provides solutions for the Pharmaceutical, Biotechnology, Chemical, Food, and Medical Devices industries in the following areas: Laboratory, Compliance, Computer, Engineering, Project Management, Validation, and other services.

We are seeking a talented, dedicated individual committed to work under the highest ethics standards for the following position:

Sr. Engineer for Medical Devices

Summary of Position with General Responsibilities:

Leads the technical support to new product transfers and/or product development projects. Possesses technical responsibility for interpreting, planning, organizing, executing, coordinating, and carrying out technical assignments based on diversified requirements.

Essential Job Functions:

• Coordinates and Supports Suppliers for Manufacturing of Custom Equipment/Tooling

• Coordinates purchase and delivery of Equipment/Tooling
• Coordinates installation of Equipment/Tooling
• Develops and Executes IQ and OQ Protocols and Reports
• Develops and Executes Usage Requirements Specifications and Factory Acceptance Tests
• Develops and Executes Test Method Validations / Gage R&R
• Generates and Issues for Approval SOPs and Manufacturing Procedures
• Develops and Executes Component Qualifications
• Develops and Executes PQ and PPQ Protocols and Reports
• Designs / Coordinates Facilities Modifications
• Creates / Coordinates Manufacturing Line Layout
• Develops Manufacturing Capacity Analysis
• Designs Equipment and Tooling
• Develops and Executes Process Characterizations / Design of Experiments (DOE)
• Develops and Maintains Project Timeline / Plan
• Develops documentation/justification for assigned capital projects
• Complies with cGMP’s, Quality Standards, and established policies and procedures
• Executes other duties assigned by his supervisor

Basic Qualifications:

• Bilingual - English and Spanish (oral and written)
• Technical writing skills
• GMP, ISO, EHS and Statistical regulations knowledge
• Strong Computer Skills/Knowledge (Word, Excel, PowerPoint)
• MS Project knowledge
• Minitab Proficiency
• SolidWorks Proficiency

Additional Desirable Qualifications Skills and Knowledge:

• Engineering Post Graduate Degree (Masters / PhD)
• Lean / Six sigma Training/Certification
• Project Management Training/Certification
• Engineering Board Certification (EIT / PE)

Education and/or Experience:

• Bachelor’s Degree in Engineering
• Experience in the Medical Device / Pharmaceutical Industries: Yes
• 5+ years of experience in the following fields:
  • Manufacturing
  • New Product Transfers
  • Product / Process Development
• Job Functions Experience in the following:
  • Qualification / Validation (IQ/OQ/PQ)
  • Test Method Validation / Gage R&R
  • Packaging Validation
  • Process Characterization / Design of Experiments (DOE)
  • Manufacturing Line Design / Capacity Analysis
  • Equipment / Tooling Design
  • Equipment Installation / Preventive Maintenance Procedure Generation
  • Root Cause Analysis / Investigation
  • SOP / Manufacturing Procedures Generation & Change Control
  • Product Financials & Supply Chain Structure Design
  • OEE Integration, Vertical Start up and Zero-loss mindset

Job Description

Job Description

Validation & Engineering Group, Inc. (V&EG) is a leading services supplier who provides solutions for the Pharmaceutical, Biotechnology, Chemical, Food, and Medical Devices industries in the following areas: Laboratory, Compliance, Computer, Engineering, Project Management, Validation, and other services.

We are seeking a talented, dedicated individual committed to work under the highest ethics standards for the following position:

Sr. Engineer for Medical Devices

Summary of Position with General Responsibilities:

Leads the technical support to new product transfers and/or product development projects. Possesses technical responsibility for interpreting, planning, organizing, executing, coordinating, and carrying out technical assignments based on diversified requirements.

Essential Job Functions:

• Coordinates and Supports Suppliers for Manufacturing of Custom Equipment/Tooling

• Coordinates purchase and delivery of Equipment/Tooling
• Coordinates installation of Equipment/Tooling
• Develops and Executes IQ and OQ Protocols and Reports
• Develops and Executes Usage Requirements Specifications and Factory Acceptance Tests
• Develops and Executes Test Method Validations / Gage R&R
• Generates and Issues for Approval SOPs and Manufacturing Procedures
• Develops and Executes Component Qualifications
• Develops and Executes PQ and PPQ Protocols and Reports
• Designs / Coordinates Facilities Modifications
• Creates / Coordinates Manufacturing Line Layout
• Develops Manufacturing Capacity Analysis
• Designs Equipment and Tooling
• Develops and Executes Process Characterizations / Design of Experiments (DOE)
• Develops and Maintains Project Timeline / Plan
• Develops documentation/justification for assigned capital projects
• Complies with cGMP’s, Quality Standards, and established policies and procedures
• Executes other duties assigned by his supervisor

Basic Qualifications:

• Bilingual - English and Spanish (oral and written)
• Technical writing skills
• GMP, ISO, EHS and Statistical regulations knowledge
• Strong Computer Skills/Knowledge (Word, Excel, PowerPoint)
• MS Project knowledge
• Minitab Proficiency
• SolidWorks Proficiency

Additional Desirable Qualifications Skills and Knowledge:

• Engineering Post Graduate Degree (Masters / PhD)
• Lean / Six sigma Training/Certification
• Project Management Training/Certification
• Engineering Board Certification (EIT / PE)

Education and/or Experience:

• Bachelor’s Degree in Engineering
• Experience in the Medical Device / Pharmaceutical Industries: Yes
• 5+ years of experience in the following fields:
  • Manufacturing
  • New Product Transfers
  • Product / Process Development
• Job Functions Experience in the following:
  • Qualification / Validation (IQ/OQ/PQ)
  • Test Method Validation / Gage R&R
  • Packaging Validation
  • Process Characterization / Design of Experiments (DOE)
  • Manufacturing Line Design / Capacity Analysis
  • Equipment / Tooling Design
  • Equipment Installation / Preventive Maintenance Procedure Generation
  • Root Cause Analysis / Investigation
  • SOP / Manufacturing Procedures Generation & Change Control
  • Product Financials & Supply Chain Structure Design
  • OEE Integration, Vertical Start up and Zero-loss mindset