Thermo Fisher Scientific Sr Validation Associate in Greenville, North Carolina
Provides direct quality support (e.g. compliance, regulatory assessment, validation) to the business unit, clients and corporate management. Facilitates activities/projects with moderate complexity, perform quality functions to ensure accurate and timely completion with frequent decision making required. Creates reviews, approves, tracks and presents documents required for compliance with pharmaceutical regulations. Identifies areas of non-compliance and assist in the resolution of major issues. Performs activities across key quality functionsas needed to ensure full support of business units.
Prepares reviews and approves validation, hold, investigation and audit reports; gains multidisciplinary consensus; makes recommendations to management based on review and analysis of data.
Manages schedules, executes and tracks multiple project activities of moderate complexity with multi-disciplinary departments to ensure timely completion of deliverables.
Analyzes data to determine trends, acceptability, identify deviations and assure resolution of deviations.
Conducts deviation investigations, such as validation failures, complaints and hold investigations. Identifies appropriate corrective actions.
Assesses impact of changes in systems, critical documentation, processes and suppliers.
Identifies critical parameters/processes and takes appropriate actions to ensure adequate controls are in place. Performs and assists with risk assessments for processes and systems.Interacts during client and regulatory audits.
Leads audits and/or assists with regulatory audits.
Provides training in area of expertise within Validation.
Works in a safe and responsible manner in order to create an injury-free and incident-free workplace.
Complies with all job-related safety and other training requirements.
Performs other duties as assigned.
Bachelor’s degree in related field is required.
Three years of relevant experience in Life Science, Chemistry, Biology, Engineering, Biomedical, or IT is preferred.
Equivalent combinations of education, training, and relevant work experience may be considered.
Familiarity with the pharmaceutical industry or other regulated industry, proficient in the use of computerized office applications (e.g. Word, Excel), project management and demonstrated scientific writing skills. Knowledge of Current Good Manufacturing Practices (cGMPs) and FDA/industry expectations. Outstanding attention to detail and organizational skills. Self-starter, mature, independent and dependable. Ability to work in a fast paced environment under pressure, able to multi-task and is results-oriented. Effective time management and prioritization skills. Requires discretion and independent judgment. Highly effective verbal and written communication skills.
Position requires ordinary ambulatory skills and physical coordination sufficient to move about office locations; ability to stand, walk, stoop, kneel, crouch periodically for prolonged periods of time; manipulation (lift, carry, move) of light to medium weights of 10-35 pounds and occasionally pushing or pulling more than 100 pounds; arm, hand and finger dexterity, including ability to grasp and type for prolonged periods of time; visual acuity to use a keyboard, computer monitor, operate equipment, and read materials for prolonged periods of time; ability to sit, reach with hands and arms, talk, and hear for prolonged periods of time.
Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.