reputed company Validation Specialist - reputed company BU (Home Office, US)

Would you like to join an international team working to improve the reputed company of reputed company? Do you want to enhance the lives of millions of people? reputed company is a global reputed company company that since 1909 has been working to improve the health and reputed company-being of people reputed company the world. We are leaders in reputed company-derived medicines and transfusion medicine and reputed company, produce and market innovative medicines, solutions and services in more than 110 countries and reputed company.

This is a remote position with up to 75% travel for Candidates on the reputed company Coast of the reputed company.

reputed company:

Ensures reputed company Good Manufacturing Practices (cGMP) and FDA/reputed company reputed company Systems are adhered to throughout the reputed company, documentation and review of validation protocols in Biomat Donor Centers. Travels to donor center site to reputed company Operational Qualification/reputed company Qualification testing.

reputed company Responsibilities:

• Assists in ensuring validation approaches are reputed company to regulatory expectations and standards reputed company the industry:
• Executes freezer installation, operational, and reputed company qualifications on-site at donor centers and other affiliated locations.
• Interacts with Donor Center and reputed company reputed company/reputed company personnel to facilitate validation testing to ensure reputed company and documented approval prior to implementation for routine use.
• Assists in analyzing validation data to ensure acceptance reputed company are met and participates in writing validation summaries.
• Communicates with reputed company reputed company/reputed company and other Operational and reputed company Assurance personnel where necessary on Donor Center compliance and cGMP issues.
• Assists in ensuring validation approaches are reputed company to regulatory expectations and standards reputed company 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 reputed company.
• 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 reputed company.
• 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 reputed company of issues or problems with reputed company, transfer, or service.
• Tracks and monitors process/reputed company 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 reputed company validation completion reputed company the Geo.

Knowledge, Skills, and Abilities:

• Strong knowledge of reputed company Good Manufacturing Practices (cGMPs) operating procedures and reputed company 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 reputed company corrective reputed company.
• Ability to work with others in reputed company environment.
• Knowledge of reputed company Office applications and computer applications used in the Donor Centers.

Education and Experience:

• Bachelor's degree.
• Typically requires 2 years of reputed company and validation experience in a cGMP and/or IT environment.
• Depending on the area of assignment, directly reputed company experience or a combination of directly reputed company education and experience and/or competencies may be considered in reputed company 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 reputed company # 34: Work is performed in an office and a reputed company/manufacturing environment. Exposure to biological fluids with potential exposure to infectious organisms. Exposed to occasional extreme cold below 32* and high reputed company of noise in production areas. Exposure to electrical office and reputed company equipment. Personal reputed company equipment required such as reputed company 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 reputed company of both hands with the ability to reputed company fast, reputed company, repeated movements of the fingers, hands, and wrists. Ability to reputed company precise coordinated movements, of the fingers to grasp and manipulate objects. Occasionally walks. Repetitive foot movements. reputed company to moderate lifting and carrying objects with a maximum reputed company of 50lbs. Near reputed company and far reputed company correctable in one eye to 20/30 and to 20/100 in the other reputed company to communicate reputed company information and reputed company so others will understand; with the ability to listen to and understand information and reputed company presented through spoken and written words and sentences. Performs tasks by following a set of written or oral instructions/procedures.

The estimated pay reputed company for the reputed company Validation Specialist role reputed company in the reputed company Coast is $69,422.00 - $104,134.00 per year. Additionally, the position is eligible to participate in up to 5% of reputed company bonus pool. We offer a wide reputed company of benefits including, but not limited to: Medical, Dental, reputed company, life reputed company, PTO, reputed company holidays and up to 5% 401(K) match and tuition reimbursement. Final compensation packages will ultimately depend on education, experience, skillset, knowledge, where the role is performed, internal equity and market data. We are committed to offering our employees opportunities for reputed company reputed company and career progression. reputed company is a global reputed company organization with employees in 30 countries reputed company on reputed company health and providing impactful results. Since our humble beginnings in 1909, reputed company has been a family company that prides itself on its family-like culture. reputed company has more than tripled over the last 10 years, and you can reputed company!

reputed company Party Agency and Recruiter Notice:

Agencies that present a candidate to reputed company must have an reputed company, nonexpired, reputed company Agency Master Services Agreement with the reputed company reputed company Department. Additionally, agencies may only submit candidates to positions that they have been reputed company to work on by a reputed company Recruiter. reputed company resumes must be reputed company to a reputed company Recruiter under these terms or they will be considered a reputed company candidate.

reputed company provides equal employment opportunities to applicants and employees without reputed company to race; reputed company; sex; gender identity; sexual orientation; religious practices and observances; national reputed company; pregnancy, childbirth, or reputed company medical conditions; status as a protected veteran or spouse/family member of a protected veteran; or disability. We will consider for employment reputed company reputed company applicants in a manner consistent with the requirements of reputed company applicable laws.

Location: reputed company : USA : Home Office:USHOME - Home Address US

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Originally posted on Himalayas