Field Validation Specialist - South BU
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Would you like to join an international team working to improve the future of healthcare? Do you want to enhance the lives of millions of people? Grifols is a global healthcare company that since 1909 has been working to improve the health and well-being of people around the world. We are leaders in plasma-derived medicines and transfusion medicine and develop, produce and market innovative medicines, solutions and services in more than 110 countries and regions. |
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This is a remote position with up to 75% travel for candidates in the Central or East Coast of the United States.
Summary:
Ensures current Good Manufacturing Practices (cGMP) and FDA/Grifols Quality Systems are adhered to throughout the performance, documentation and review of validation protocols in Biomat Donor Centers. Travels to donor center site to perform Operational Qualification/Performance Qualification testing.
Primary Responsibilities:
- Assists in ensuring validation approaches are current to regulatory expectations and standards within the industry:
- Executes freezer installation, operational, and performance qualifications on-site at donor centers and other affiliated locations.
- Interacts with Donor Center and Field Quality/Operations personnel to facilitate validation testing to ensure timely and documented approval prior to implementation for routine use.
- Assists in analyzing validation data to ensure acceptance criteria are met and participates in writing validation summaries.
- Communicates with Field Quality/Operations and other Operational and Quality Assurance personnel where necessary on Donor Center compliance and cGMP issues.
- Assists in ensuring validation approaches are current to regulatory expectations and standards within the industry:
- Writes test cases to validate critical control points, user requirements, and functional designs.
- Executes test cases as needed.
- Prepares validation reports for distribution.
- Ensures milestones and timelines are met on assigned projects.
- Participates in the evaluation of processes, systems, and individual center equipment needs and final approval process:
- Prepares validation equipment for use at the Donor Center and for evaluation upon return.
- Assists in identifying and determining actions to add, remove, and/or revalidate processes, systems, and equipment including evaluation of new/updated methodologies/applications/equipment and resolution of issues or problems with performance, transfer, or service.
- Tracks and monitors process/system failures/events. Provides feedback to Donor Center management regarding requirements, results from data collected, and validation processes.
- Tracks and monitors equipment calibration due dates and calibration failures/events. Provides feedback to Donor Center management regarding equipment calibration due dates, requirements, results from data collected, and validation processes.
- Prepares donor center staff for validation activity as necessary and conducts training with donor center teams where applicable.
- Travels on-site up to 75% as needed to ensure timely validation completion within the Geo.
Knowledge, Skills, and Abilities:
- Strong knowledge of current Good Manufacturing Practices (cGMPs) operating procedures and standard operating procedures.
- Excellent quantitative and analytical skills.
- Excellent oral and written communication skills.
- Strong critical thinking and problem solving skills.
- Ability to identify errors and provide corrective action.
- Ability to work with others in a team environment.
- Knowledge of Microsoft Office applications and computer applications used in the Donor Centers.
Education and Experience:
- Bachelor's degree.
- Typically requires 2 years of quality and validation experience in a cGMP and/or IT environment.
- Depending on the area of assignment, directly related experience or a combination of directly related education and experience and/or competencies may be considered in place of the stated requirements. Example: If a job level requires a Bachelor’s degree plus 4 years of experience, an equivalency could include 8 years of experience, an Associate’s degree with 6 years of experience, or a Master’s degree with 2 years of experience.
Occupational Demands:
Occupational Demands Form # 34: Work is performed in an office and a laboratory/manufacturing environment. Exposure to biological fluids with potential exposure to infectious organisms. Exposed to occasional extreme cold below 32* and high levels of noise in production areas. Exposure to electrical office and laboratory equipment. Personal protective equipment required such as protective eyewear, garments and gloves. Frequently sits for 4-6 hours per day. May stand; bends and twists neck and waist for 2-4 hours per day. Repetitive hand movement of both hands with the ability to make fast, simple, repeated movements of the fingers, hands, and wrists. Ability to make precise coordinated movements, of the fingers to grasp and manipulate objects. Occasionally walks. Repetitive foot movements. Light to moderate lifting and carrying objects with a maximum lift of 50lbs. Near vision and far vision correctable in one eye to 20/30 and to 20/100 in the other eye. Able to communicate complex information and ideas so others will understand; with the ability to listen to and understand information and ideas presented through spoken and written words and sentences. Performs tasks by following a set of written or oral instructions/procedures.
Pay scale of $69,422.00 - $104,134.00 per year for US Residents depending on training, education and experience. This position is eligible to participate in up to 5% of the company bonus pool. We offer benefits including medical, PTO, up to 5% 401K match, and tuition reimbursement. We are committed to offering our employees opportunities for professional growth and career progression. Even though we are a global healthcare company with employees in 30 countries, Grifols prides itself on its family-like culture. Our company has more than tripled its workforce in the last 10 years — we’re growing, and you can grow with us!
Third Party Agency and Recruiter Notice:
Agencies that present a candidate to Grifols must have an active, nonexpired, Grifols Agency Master Services Agreement with the Grifols Talent Acquisition Department. Additionally, agencies may only submit candidates to positions that they have been engaged to work on by a Grifols Recruiter. All resumes must be sent to a Grifols Recruiter under these terms or they will be considered a Grifols candidate.
Grifols provides equal employment opportunities to applicants and employees without regard to race; color; sex; gender identity; sexual orientation; religious practices and observances; national origin; pregnancy, childbirth, or related medical conditions; status as a protected veteran or spouse/family member of a protected veteran; or disability. We will consider for employment all qualified applicants in a manner consistent with the requirements of all applicable laws.
Location: NORTH AMERICA : USA : Home Office:[[cust_building]]
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