Quality Control Specialist

Pay range: 30-40/hr
*depending on experience

?The QC Chemistry Specialist plays a critical role in ensuring the successful establishment and ongoing support of the Quality Control Chemistry laboratory in a GMP-regulated environment. This individual is responsible for leading laboratory readiness efforts, overseeing analytical method transfers and validations, and ensuring compliance with data integrity and regulatory expectations. The QC Chemistry Specialist functions as a subject matter expert (SME), providing technical and operational guidance while driving continuous improvement.
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Key Responsibilities:
• Lead QC Chemistry activities, including analytical instrument qualification, method transfers, and validation of laboratory systems and processes.
• Review and contribute to validation documentation supporting onboarding of equipment and computerized systems.
• Author, revise, and review a range of technical and quality documents, including SOPs, test methods, qualification protocols/reports, method and technical assessments, and trend reports.
• Support procurement and readiness of laboratory consumables and critical reagents for lab operation.
• Coordinate and execute training and method transfers for chromatography-based methods (HPLC, UPLC), TOC, and related bench-top analytical instrumentation.
• Own and manage Quality System records, including Deviations, CAPAs, and Change Controls.
• Support internal and external audits and represent the QC Chemistry function in cross-functional and global initiatives.
• Provide operational support for testing or system needs during weekends and public holidays, as required.
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Required Qualifications:
• Bachelors degree in chemistry, Biochemistry, Chemical Engineering, or a related scientific discipline.
• Minimum of 4 years of QC or analytical laboratory experience in a GMP-regulated pharmaceutical or biopharmaceutical environment.
• Proficient in chromatography techniques (HPLC/UPLC), TOC analysis, and general laboratory instrumentation.
• Experience with analytical method validation, transfer, verification, and equipment qualification.
• Demonstrated ability to manage quality records (e.g., Deviations, CAPAs, Change Controls) independently.
• Proficient in laboratory systems such as LIMS and electronic quality systems (e.g., LMES/CIMS).
• Strong understanding of regulatory and industry compliance standards, including data integrity principles.
• Excellent technical writing and verbal communication skills.
• Proven ability to work independently and collaboratively in a fast-paced, dynamic environment.
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Preferred Qualifications:
• Experience supporting new laboratory startup or facility buildout projects.
• Prior participation in regulatory inspections or third-party audits.
• Familiarity with ICH guidelines and USP general chapters relevant to chemical analysis.