Work Schedule
Standard (Mon-Fri)
Environmental Conditions
Office
Job Description
Division/Site Specific Information
Position is based High Point, North Carolina. Position will support our Drug Product Division (DPD) at Thermo Fisher Scientific.
Discover Impactful Work:
The Quality Control Specialist acts as a senior technical leader within the chemistry or microbiological quality control environment. Independently evaluates complex analytical, compendial, technical transfer, specification, change control, and quality system activities in support of pharmaceutical development, manufacturing, and commercial operations. Authors and manage test method lifecycle activities, risk assessments, reduced testing programs, quality system documentation, electronic document management activities, SAP quality data updates, and client-driven quality changes.
Day in the Life:
- Interprets, verifies, and approves analytical data; leads quality initiatives through participation on group and department project teams; mentors junior team members; and advises on best practices, technical challenges, and industry trends.
- Leads method lifecycle activities, including analytical gap assessments, method transfer, qualification, validation, and implementation of new or revised test procedures and specifications.
- Assesses compendial updates for potential impact, authors compendial revision assessment protocols and reports, and initiates associated changes to test procedures, specifications, quality documents, or quality system records.
- Owns or supports change controls for test procedures, specifications, reduced testing programs, client-requested changes, raw material changes, and associated quality system updates from initiation through approval and publication.
- Partners with technical, quality, and client-facing teams to evaluate raw material manufacturer changes, alternate or new manufacturers, and related risk assessments, including necessary updates to specifications and test procedures.
- Authors, revises, routes, and maintains quality documents, including analytical protocols, reports, work instructions, standard operating procedures, specifications, test procedures, and policy or instructional documents.
- Maintains quality system and electronic document management activities, including document approval routing, periodic reviews, document publication, and subject matter expert support for controlled documentation systems.
- Supports SAP quality activities, including new or revised material master quality data, certificate of analysis configuration, reduced testing profiles, inspection lot activities, and updates related to revised specifications or procedures.
- Authors and revises elemental impurity and residual solvent assessments for new materials, additional manufacturers, manufacturer changes, and other quality or regulatory-driven updates.
- Communicates technical conclusions clearly and accurately through documented analysis, reports, client interactions, cross-functional communications, and presentations to internal stakeholders or external partners.
Keys to Success:
Education:
Bachelor’s degree in a physical science, preferably Chemistry, Biology, Microbiology, or a related scientific discipline. Master’s degree in Chemistry, Biology, Microbiology, or a related scientific discipline preferred.
Experience and Qualifications:
Requires a minimum of 8 years of experience performing tests, analyses, technical documentation, method lifecycle activities, quality systems work, or related quality control support for pharmaceutical raw materials, finished products, microbiological samples, stability samples, or commercial manufacturing operations.
Competencies:
- Strong knowledge of GMP, GLP, data integrity, controlled documentation, and pharmaceutical quality systems.
- Proficient with analytical techniques including HPLC, GC, LC/MS, dissolution, spectroscopy, wet chemistry, and method validation.
- Experienced in change control, technical transfer, specification management, risk assessment, reduced testing, and SAP quality processes.
- Advanced problem-solving skills with the ability to resolve complex scientific, quality, and documentation challenges.
- Excellent written, verbal, presentation, and client-facing communication skills.
- Proven leadership, mentoring, prioritization, and cross-functional collaboration abilities.
- Skilled in interpreting technical procedures, regulatory guidance, and quality system requirements.
- Experienced in authoring and revising SOPs, specifications, protocols, reports, and quality documents.
- Capable of managing complex customer, stakeholder, and regulatory inquiries.
Physical Requirements:
- Capable of standing, walking, stooping, kneeling, and crouching for extended periods.
- Able to lift, carry, and move materials weighing 10–35 lbs.
- Strong hand and finger dexterity for equipment operation, typing, and laboratory tasks.
- Visual acuity to operate instruments, use computers, and review technical documents.
- Ability to sit, reach, communicate, and hear effectively for prolonged periods.
- Wear required PPE, including safety glasses, safety shoes, lab coat, gloves, apron, and respirator as needed.
Excellent Benefits
OTHER
- Relocation assistance is NOT provided
- Must be legally authorized to work in the United States now or in the future, without sponsorship.
- Must be able to pass a comprehensive background check, which includes a drug screening.