Grifols

General

• Perform physical examination and establish medical history to determine donor suitability
• Build rapport with donors to ensure overall customer satisfaction
• Ensure donor and staff confidentiality
• Responsible for donor awareness to potential hazards
• Provide donor education regarding general health and provide counseling regarding unacceptable test results
• Evaluate & manage donor injuries and adverse events
• Perform evaluations of any history of illness or medications to ensure continued donor suitability
• Assist in employee training
• Administer employee Hepatitis Vaccine program

EMTB / EMTA or Paramedic / LPN, Part Time

Assistant

• Responsible for performing complex laboratory analysis of plasma and plasma products in a GMP laboratory.
• Responsibilities include sample accessioning, sample preparation, reagent preparation, testing, result calculation, as well as quality control of assays and equipment.
• Support assay validation, method transfer, reagent and control qualification, and laboratory maintenance activities as assigned.
• This position is responsible for performing bioburden and endotoxin testing of in-process product samples and raw materials to support plasma production processes, including process and equipment activities.

Assistant – Biologist

Phlebotomist

• Assist in determining the suitability of donors
• Establish rapport with donors
• Respond to donor reactions
• Monitor donor and equipment health
• Set up and operate plasmapheresis machines

• Assist in determining the suitability of donors.
• Establish rapport with donors to ensure overall customer happiness while ensuring donor confidentiality.
• Respond to and assist with handling donor reactions.
• Monitor donor and equipment to ensure health of donors and quality of product.
• Set up, disconnect, and operate the automated plasmapheresis machines.

Technician

• Conducts pre-donation medical screening
• Interaction and responsiveness to customer needs
• Assesses donor suitability and engages in set-up
• Provides appropriate feedback to ineligible donor candidates
• Ensures all donor screening information is complete
• Ensures donor confidentiality

Donor Center Technician

• Assist in determining the suitability of donors
• Establish rapport with donors to ensure overall customer happiness
• Respond to and assist with handling donor reactions
• Monitor donor and equipment to ensure health of donors and quality of product
• Set up, disconnect, and operate automated plasmapheresis machines
• Disconnect and dispose of all contaminated disposable equipment

• Assist in determining the suitability of donors
• Establish rapport with donors to ensure overall customer happiness
• Ensure donor confidentiality
• Respond to and assist with handling donor reactions
• Monitor donor and equipment to ensure health of donors and quality of product
• Set up, disconnect, and operate the automated plasmapheresis machines
• Disconnect and dispose of all contaminated disposable equipment

• Assist in determining the suitability of donors
• Establish rapport with donors to ensure overall customer happiness while ensuring donor confidentiality
• Respond to and assist with handling donor reactions
• Monitor donor and equipment to ensure health of donors and quality of product
• Set up, disconnect, and operate the automated plasmapheresis machines
• Disconnect and dispose of all contaminated disposable equipment

Operations

• Responsible for all aspects of the donor center when the Center Manager is not present.
• Collaborates with Training and Quality staff to ensure that training and quality goals are met.
• Coaches and leads through effective feedback to employees through the Operations Supervisor(s).
• Monitor and evaluate operations.
• Works with the Center Manager to develop action plans to maximize center efficiency and supervises the implementation of improvements.
• Makes critical decisions for the modifications of action plans.
• Responsible for all personnel functions including hiring, assignment and direction of work, development and training, disciplinary actions and termination and the maintenance of all personnel records
• Partners with the Center Manager in budget preparation and oversees facility to achieve production targets and quality goals at the agreed-upon cost structure.
• Actively delegates, monitors, and holds responsible the operations supervisors for their performance.
• Direct and supervise employees. This includes creating and managing work schedules.
• Establishes and maintains the ability to perform all tasks within the center; fulfills the role of production employees when the occasional need arises.
• Assures center employees maintain the facility in a neat and clean condition and all equipment is kept in good working order.
• Responsible for freezer management, including overseeing plasma shipments and equipment failures.
• Develop and implement active donor recruitment advertising campaigns to improve production levels.
• Maintains thorough familiarity and ensures compliance with state and federal regulations, U.S. Food and Drug Administration (FDA)-approved Standard Operating Procedures, Occupational Safety and Health Administration (OSHA), Clinical Laboratory Improvement Amendments (CLIA), and Current Good Manufacturing Practice (cGMP).

Operations Manager – Plasma Center

Supervisor

• Directs shift operations and ensures product integrity according to production schedule and safety regulations
• Maintains floor presence to minimize discrepancies and promote compliance
• Participates in process/product troubleshooting
• Acts as initial point of contact for partner groups
• Manages employee performance and ensures timely training

Manufacturing Supervisor I – PFF

• Directs shift operations and ensures product integrity in accordance with the production schedule, cGMP, safety regulations and policies & procedures.
• Maintains floor presence to minimize discrepancies and promote process compliance and accurate documentation.
• Participates in process/product troubleshooting in order to correct/maintain desirable process parameter.
• Acts as an initial point of contact for partner groups (i.e. Maintenance, Quality, Tech Doc Support, etc.)
• May recommend and with direction, implement measures to improve production methods, equipment performance, facility layout and quality of product.
• Manage employees performance, coach and counsel for development.
• Ensures required training for employee is achieved, effective and timely.

Manufacturing Supervisor I

Associate

• Responsible for quality oversight of the final container inspection and packaging operations
• For example, AQL (Acceptable Quality Limit) sampling and inspection of packaged final container product
• Packaging area release, quality verification of first print and last print samples
• Lot reconciliation, etc.
• Perform Label Control duties
• i.e. inventory count and issuance of labels and inserts for the packaging process
• Receive, store and inspect retention samples (includes intermediates and final container products)
• Inspect and release finished product produced in Instituto Grifols
• Perform annual inventory of quarantine areas and quarterly inventory of label control areas
• Perform distribution release verification of intermediates and final container products
• Perform packaging work order review
• Perform various SAP transactions from the processes mentioned above
• Strict adherence to procedures and practices according to FDA regulations
• Strong emphasis on documentation according to FDA regulations
• Adhere to departmental corporate safety policies

QO Associate

Quality Specialist

• Conducts compliance audits of difficult & complex documentation and data
• Approve use of Design History Records, Device Master Records, Nonconformances, Document Changes, Validations and Change Controls
• Demonstrates working knowledge of Quality Control, Manufacturing and Inventory processes
• Leads internal, external & 3rd party audits
• Reviews Customer Notifications and prepare, approve & submit data packages for external customers
• Supports internal and/or external audits in compliance with ISO 13485 and 21CFR820 requirements
• Participates in 3rd Party Audits from regulatory bodies including the FDA, notified bodies and business partners
• Assists in developing quality systems & make recommendations for improvements to existing Quality systems
• Approves compliance assessments & interfaces with other departments

• Provides overall strategic direction and guidance to the operational activities of the Canada plasma donor center organization
• Directs and full responsibility over Plasma operations in Canada
• Approves budgets, plans and goals for the control of the planned production, budgeted spending, labor efficiency, material efficiency
• Directs and oversees operational activities and projects to ensure business goals are achieved and results are in line with the stated objectives
• Assists in the development of the Canada plasma operations strategic plan to advance the Company's mission and objectives
• Implements programs to ensure attainment of business plans for growth and profit
• Oversees team of senior leaders and the general manager and field levels
• Approves divisional operating procedures, policies, and standards in compliance with FDA, EMA, and other regulatory standards
• Develops and maintains the headcount, capital forecasts, and operational expense budgets for plasma production
• Directs, appraises and sets appropriate measurement targets for the performance of all operational functions of the donor centers
• Responsible for the proper integration of newly acquired donor centers
• Implements improved processes and management methods to generate higher return on investment (ROI) and workflow optimization

EMTB / EMTA or Paramedic / LPN, Part Time

Assistant – Biologist

Phlebotomist

Phlebotomist

Donor Center Technician

Donor Center Technician

Phlebotomist

Phlebotomist

Phlebotomist

Operations Manager – Plasma Center

Manufacturing Supervisor I – PFF

Manufacturing Supervisor I

QO Associate

Quality Specialist

Vice President, Plasma Operations