Quality Specialist I

Work Schedule

12 hr shift/days

Environmental Conditions

Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.)

Job Description

As part of the Thermo Fisher Scientific team, you'll discover meaningful work that makes a positive impact on a global scale. In this role, you will help ensure the highest quality standards across our operations, supporting our Mission to enable our customers to make the world healthier, cleaner, and safer. As a Quality Specialist, you will collaborate cross-functionally to strengthen quality systems, drive continuous improvement, and ensure regulatory compliance in a highly regulated pharmaceutical manufacturing environment.

Schedule: Thursday-Saturday 6:00am-6:30pm

DESCRIPTION:

• Review with minimum Supervision Manufacturing and/or Packaging batch records in accordance with applicable GMP/GDP/ALCOA requirements (including raw E-Data Review) to ensure batch records are compliant with approved site SOPs prior to batch release activities, ensuring to deliver on agreed schedule.
• Follow up with Technicians/Supervisors/Scientists to ensure all documentation errors are completed timely and in accordance with GMP standards.
• Perform SAP material charge-offs batch status updates for each reviewed section in accordance with site procedures.
• Serve as a quality resource for batch record corrections, providing guidance to manufacturing personnel on proper correction completion.
• Support correction-related questions to ensure documentation updates meet GDP requirements and site procedures.
• Complete preliminary release activities, including creation of in-process batch cards for products proceeding to through formulation manufacturing or packaging.
• Maintain a safe working environment and report potential hazards.
• Perform alternating or rotating shift work (as required)

REQUIREMENTS:

• High School Diploma or GED required
• 3-5 years of experience in pharmaceutical manufacturing, biologics, or regulated manufacturing environments.
• Experience in quality assurance or operations within GMP environment (pharmaceutical, biotech, or medical device preferred)
• Experience with batch record review preferred.
• Familiarity with SAP or other ERP systems preferred.
• Strong working knowledge of cGMP, GDP, and FDA/EMA regulatory expectations.
• Understanding of pharmaceutical manufacturing processes and cleanroom operations.
• Familiarity with batch record documentation and data integrity principles.
• Strong attention to detail and documentation accuracy
• Effective communication and on-the-floor coaching ability
• Ability to identify compliance gaps and drive immediate corrective actions
• Organizational and time-management skills
• Strong verbal and written communication skills
• Strong interpersonal skills with the ability to collaborate across functions and levels
• Problem-solving and root cause analysis capabilities
• Ability to make sound quality decisions in real time
• Ability to work effectively in controlled manufacturing environments
• Ability to balance compliance requirements with operational efficiency
• Ability to collaborate cross-functionally and escalate issues appropriately
• Ability to work independently to consistently meet daily and weekly expectations