Quality Specialist I

Thermo Fisher Scientific•Florence, SC

1d•Onsite

About The Position

As part of the Thermo Fisher Scientific team, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner, and safer. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the world’s toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer. Position will sit onsite at the Florence, SC site and will support the Drug Substance Division (DSD) at Thermo Fisher Scientific. This role, reporting to the Production Planning Manager, ensures the flawless import of materials and goods at our Florence, South Carolina locations. Discover Impactful Work: Join our high-performing team at Thermo Fisher Scientific, where you'll ensure quality compliance across manufacturing operations while advancing our mission to make the world healthier, cleaner, and safer. As a Quality Specialist I, you'll provide essential quality oversight through detailed documentation review, process monitoring, and collaboration with cross-functional teams. You'll help maintain GMP compliance, investigate quality events, and drive continuous improvement initiatives while working in a collaborative environment focused on delivering life-changing products to our customers. Under general supervision, provide comprehensive manufacturing technical support and quality assurance oversight to meet good business practices and the requirements of applicable regulatory agencies, supporting one of the following areas: API manufacturing, testing, disposition, quality systems and distribution of bulk drug substance.

Requirements

High school diploma, or equivalent.
High school diploma with 3–5 years of experience in pharmaceutical or biological manufacturing, or another regulated industry; or a bachelor’s degree in a technical science or engineering field with 0–3 years of Quality Assurance experience.
Experience conducting quality investigations and root cause analysis.
Thorough knowledge of FDA, EMA, and international GMP regulations
Proven ability to review and approve GMP documentation, batch records, and quality records
Strong understanding of quality management systems and tools (e.g. CAPA, change control)
Excellent documentation and technical writing skills
Proficiency with quality systems software and Microsoft Office applications
Strong analytical and problem-solving abilities with keen attention to detail
Outstanding verbal and written communication skills
Ability to work independently and collaborate effectively across functions
Knowledge of environmental monitoring and contamination control principles
Flexibility to work various shifts as needed to support manufacturing operations
Ability to gown and work in controlled manufacturing environments when required
Physical capability to stand, walk, and lift up to 25 pounds occasionally
Sound judgment and decision-making skills
Commitment to maintaining a quality-focused culture and driving continuous improvement
Fluency in English required

Nice To Haves

BS Degree Preferred.
Preferred Fields of Study: Chemistry, Biology, Engineering, Life Sciences, or related scientific field
Additional relevant certifications (e.g. ISO auditor, Six Sigma) are advantageous.
additional language skills beneficial

Responsibilities

Apply technical knowledge to address a broad range of issues to ensure adherence to and compliance with established company policies and procedures, as well as requirements of applicable Regulatory Agencies by working collaboratively with one or more of the following areas: manufacturing, testing, batch disposition, quality systems (Discrepancy/Investigation, change control, CAPA), qualification-validation, and distribution of bulk drug substance.
Maintains quality management system associated documentation and all records required to manage the development, production and distribution of the products manufactured at this facility.
Provide direct support to archival and retrieval of documentation and/or drawings to and from approved storage areas.
Provide support in the monitoring and analyzing of business process performance measures and notify management of potential quality or regulatory issues that may affect product quality or regulatory compliance.
Ensure that the products are manufactured in compliance with the regulatory and in a GMP compliant manner by reviewing batch records and performing appropriate investigations.
Provide Quality Assurance support to resolving raw material, in-process material, bulk and final product, environmental, and system issues.
Assist in writing and revising site SOPs or other procedures as required.
Administer, document and maintain the company Quality Systems conformance to regulatory requirements and company policies where appropriate through effective utilization of the company’s Quality Systems and tools, as well as direct actions.
Troubleshoot and direct the resolution of Quality issues by fostering effective interdepartmental and cross functional partnerships.
Support Site Training in development, delivery and maintenance of Quality training programs (e.g., CAPA process, GMP, etc.).
Participate in audits and inspections performed by clients and regulatory agencies, as required.
Participate in the execution and/or administration of corporate Quality System tools such as TrackWise, Documentum, EDMS, etc.
Provide input to the development of personal performance goals and departmental objectives; collaborate with Management to establish and meet targets and timelines.
Participate in the design and implementation of department and cross-functional initiatives.
Maintain a state of inspection readiness.
Perform other duties as required.