Thermo Fisher Scientific Quality Assurance Analyst - GMP Services in Bend, Oregon
Assists in establishing and maintaining quality systems as they pertain to current industry, regulatory and customer requirements. Provides direct quality assurance support for cGMP Manufacturing operations.
Act as a key Quality contact to manufacturing for on the floor discrepancy management, batch review, and line support. Assures compliance with cGMP regulations, Patheon standards, and applicable regulatory requirements. Resolve routine Quality Assurance issues limited in scope and complexity following cGMP regulations and Patheon standards. Perform assigned tasks and work to achieve site goals and department objectives. Conducts periodic audits of documents such as, but not limited to, standard operating procedures. Authors, revises, reviews, approves controlled documents in compliance with cGMP regulations. Assists in internal audits to assess conformity to company procedures and practices. Distributes documentation to customers for review and approval. Performs Line-clearance for Manufacturing. Assists in the review of documentation, logbooks, and records. Assists the operations personnel in validation and revalidation processes and approves operations validation protocols. Tracks and/or manages Corrective And Preventative Action (CAPA). Reviews and approve maintenance work orders. Assists in customer and/or regulatory audits. Other duties as assigned.
Bachelor’s degree required in physical science, chemistry or related field.
Three to Six years of Quality Assurance and/or Manufacturing experience required; pharmaceutical industry preferred.
Equivalent combinations of education, training, and relevant work experience may be considered.
Good knowledge of current Good Manufacturing Practices (cGMP) required. Ability to interpret and relate Quality standards for implementation and review. Strong interpersonal skills and effective verbal and written communication skills and ability to work with internal/external clients. Strong proficiency in Microsoft Office Suite (Word, Excel, and PowerPoint). Effective written, interpersonal, and presentation skills. Ability to work on multiple projects simultaneously in a collaborative, fast-paced work environment.
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 pound 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.