Thermo Fisher Scientific Quality Specialist I in Bend, Oregon

Job Description

Summary:

Assists in establishing and maintaining quality systems as they pertain to current industry, regulatory and customer requirements. Provides quality assurance project support for current Good Manufacturing Practices (cGMP) operations.

Essential Functions:

Ensures the Document Control System meets cGMP requirements. Manages electronic document control activities in conjunction with Quality Assurance (QA) Supervisor, and produces and organizes electronic records/documentation in portable document format (pdf). Conducts periodic audits of documents such as, but not limited to, standard operating procedures. Authors, revises, reviews, approves and/or archives controlled documents in compliance with cGMP regulations. Assists in internal audits to assess conformity to company procedures and practices. Manages and/or supervises internal and external document routing processes. Distributes documentation to customers for review and approval. Assists in the development of specifications for incoming components. Acts as the document owner for Administrative and QA Standard Operating Procedures (SOPs). Reviews Production Batch Records (PBRs), SOPs, Specifications, Analytical Methods, Validation Protocols, and analytical reports. Creates Certificates of Compliance and Origin. Reviews and Approves Component/Raw Material Files. Labels inspections and performs finished product inspections. Assists in the review of documentation, logbooks, and records. Assists the operations and Quality Control (QC) personnel in validation and revalidation processes and approves operations validation protocols. Documents Out Of Specification (OOS) results and deviations. Signs deviations, OOS, investigations, etc. for manufacturing in Quality Director’s absence or as otherwise directed. Tracks and/or manages Corrective And Preventative Action (CAPA) system. Reviews and approve maintenance work orders. Trains and familiarizes new employees with the cGMP training and QA work procedures. Documents the same in appropriate training logbook s/compliance software. Assists in technical/analytical/regulatory aspects of various other company activities such as QC, Research & Development (R&D), environmental health and safety, compliance with state regulatory guidelines, hazardous waste, etc. Assists in customer and/or regulatory audits.

Education:

Bachelor’s degree required in physical science, chemistry or related field.

Experience:

Three to Six years of laboratory and Quality Assurance experience required; pharmaceutical industry preferred.

Equivalency:

Equivalent combinations of education, training, and relevant work experience may be considered.

Competencies:

Good knowledge of Good Laboratory Practices (GLP), and current Good Manufacturing Practices (cGMP) required. 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.

Physical Requirements:

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.

Summary:

Assists in establishing and maintaining quality systems as they pertain to current industry, regulatory and customer requirements. Provides quality assurance project support for current Good Manufacturing Practices (cGMP) operations.

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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.