Validation Associate I
Summary of Major Responsibilities
The Validation Associate I will participate or lead validation and qualification activities in a variety of areas, including equipment, facilities, cleaning, process and test method. The position will be responsible for protocol generation, validation execution, validation binder completion, and summary report generation. The position will be a member of project teams providing guidance on validation strategies.
Essential Duties and Responsibilities
- Write, revise, and submit validation protocols (including but not limited to Installation Qualification, Operational Qualification, Performance Qualification, Process Validation, Test Method Validation) for approval.
- Serve as reviewer or approver for documents (protocols and summary reports) prepared by other team members.
- Execute validation or qualification protocols, including equipment, facilities, cleaning, and/or process and test method validations as needed.
- Prepare executed validation binders, including identification of attachments and supporting data
- Coordinate the implementation or scheduling of validation testing with affected departments and personnel.
- Responsible for understanding, communicating, and following current Good Manufacturing Practices (cGMPs).
- Support and adhere to the Quality Policy and Quality System procedures.
- Assist operators in understanding and documenting validation execution by being present during validation execution activities performed by other groups.
- Participate in process FMEA risk assessments.
- Perform other related duties as assigned by management.
- Ability to accurately follow procedures or perform work with minimal direction.
- Strong documentation skills and attention-to-detail necessary in a cGMP environment.
- Proven ability to work effectively in team situations as well as independently.
- Excellent oral and written communication and interpersonal skills.
- Experience in a biotech manufacturing environment, preferably in a cGMP and/or ISO 13485 environment.
Education and Experience
- Bachelor’s degree in Life Sciences, or related field or the equivalent combination of education and experience.
- Hands-on experience in molecular biology techniques.
- Basic knowledge of statistical and mathematical methods in biology/genetics.
- Experience in using basic software applications including Microsoft Office.
- At least 1 year experience in validation/qualification principles and practice.
- Demonstrated experience in being an engaged and productive team member.
Exact Sciences is an equal employment opportunity employer. All qualified applicants will receive consideration for employment without regard to age, color, creed, disability, gender identity, national origin, protected veteran status, race, religion, sex, sexual orientation, and any other status protected by applicable local, state or federal law. The Company’s affirmative action program is available to any applicant or employee for inspection upon request.
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