Quality Specialist I
Thermo Fisher Scientific

Work Schedule
Rotational days/weekends

Environmental Conditions
Able to lift 40 lbs. without assistance, Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Cleanroom: no hair products, jewelry, makeup, nail polish, perfume, exposed piercings, facial hair etc... allowed, Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.), Will work with hazardous/toxic materials

Job Description

Thermo Fisher Scientific Inc. is seeking an extraordinarily dedicated and motivated Quality Specialist I to join our world-class team in Florence. This role offers a unique opportunity to supply to the detailed execution of our quality systems in a collaborative and inclusive environment. You will ensure compliance with industry, regulatory, and customer requirements, while supporting cGMP operations.

Essential Duties and Responsibilities

• Review of batch records and corresponding documentation prior to product disposition.
• Distributes and supervises controlled copies of batch operating procedures (BOP) for manufacturing campaigns.
• Aids in the development and maintenance of operational guidelines.
• Issues, tracks, and controls laboratory log sheets for all scientific personnel.
• Assists in the routine maintenance of SOPs, including periodic reviews.
• Reviews shipping documents prior to all shipments of product.
• Maintains up-to-date raw material specifications and issues controlled copies to purchasing and Quality Control.
• Issues deviation report numbers, out of specification (OOS) numbers, Corrective Action Report (CAR) numbers, and change control.
• Assists in preparation for customer visits prior to audits and collects documents during audits for review.
• Leads and conducts Document Control operations.
• Reviews QC analytical results to ensure material meets specifications and releases/rejects as instructed by findings.
• Updates control document books as new issuances/updates are issued.
• Maintains training records and updates the training record program as vital.
• Assigns SOP, Batch Record, validation, protocol, cleaning, investigation.
• Performs raw material review and disposition, maintaining computer systems.
• Cultivates relationships with raw material vendors, crafting specifications and acquiring Certificates of Analysis.
• Releases intermediates and approves OI's, test methods, and special SOPs.
• Maintains change control and investigation report systems and follow-up actions.
• Reviews and releases final products.
• Assists in maintaining compliance status of the facility.
• Effectively communicates with management.

• **Design:** Demonstrates attention to detail.
• **Problem Solving:** Identifies and resolves problems in a timely manner; works well in group problem-solving situations.
• **Customer Service:** Responds promptly to customer needs and meets commitments.
• **Interpersonal Skills:** Maintains confidentiality and listens to others without interrupting.
• **Verbal Communication:** Articulates thoughts effectively and convincingly in both favorable and unfavorable circumstances.
• **Written Communication:** Writes clearly and informatively.
• **Teamwork:** Contributes to building a positive team spirit.
• **Judgement:** Exhibits sound and accurate judgment.
• **Motivation:** Demonstrates persistence and overcomes obstacles.
• **Planning/Organizing:** Prioritizes and plans work activities; uses time efficiently.

• Prefer BS degree in Chemistry, Biology, or a related scientific field; will consider Associate's Degree (AA/AS) with two to four years of relevant experience.
• Previous Pharmaceutical or cGMP experience preferred.