Quality Control Analyst III

BioPharma Consulting JAD Group; Norton (MA); On-site; USD 60,000 - 90,000; Full time

Job summary

An established industry player is seeking a Quality Control Analyst III to uphold the highest quality standards in the pharmaceutical sector. This vital role involves executing analytical and microbiological tests, supporting method validation, and maintaining laboratory operations. You will contribute to compliance with regulatory standards while participating in continuous improvement initiatives. The position requires flexibility for weekend work and offers a collaborative environment where your expertise in quality control will directly impact product safety and efficacy. Join a forward-thinking team dedicated to excellence in quality assurance.

Qualifications

• 4+ years in GMP Quality Control in pharma/biotech.
• Experience with method transfer and analytical implementation.
• Strong problem-solving and technical writing skills.

Responsibilities

• Perform routine and non-routine assays for quality control.
• Assist in laboratory maintenance and data review.
• Collaborate with teams to ensure compliance and quality.

Skills

Analytical Skills

Problem-Solving

Technical Writing

Data Analysis

Communication

Education

B.S. in Chemistry

B.S. in Biology

B.S. in Biochemistry

Tools

LabWare LIMS

Microsoft Excel

Microsoft Word

Microsoft PowerPoint

Job description

Summary:
The Quality Control Analyst III plays a vital role in ensuring that the highest quality standards are met throughout the development and commercialization phases. This position involves executing both routine and non-routine testing, assisting with method transfers, method validation, and supporting laboratory operations. The analyst will also contribute to data trending, investigations, and laboratory maintenance. This position is critical in supporting continuous operational schedules and upholding regulatory compliance within the Quality Control department.

Responsibilities:

• Perform routine and non-routine analytical and microbiological assays to support raw materials, in-process samples, product release, and stability studies, in adherence to SOPs.
• Support weekend laboratory operations to ensure seamless testing schedules (Analytical, Microbiology, Raw Materials).
• Maintain accurate and up-to-date training records and adhere to testing schedules to ensure timely completion of tasks.
• Assist in the maintenance of laboratory equipment and inventory, including reagent and sample preparation.
• Review data in a timely manner and qualify as a data reviewer to ensure data availability and efficiency.
• Perform role-specific operational tasks, including raw material processes (SAP transactions), environmental monitoring, and in-process testing.
• Contribute to the revision of controlled documents, including SOPs, work instructions, and test methods, to ensure compliance with industry and regulatory standards.
• Adhere to internal and regulatory standards (e.g., GMP, GLP, ICH guidelines) to maintain quality and compliance.
• Participate in continuous improvement initiatives by identifying areas for enhancement in laboratory processes.
• Collaborate with QC and cross-functional teams to ensure effective quality control operations and alignment with organizational goals.
• Participate in the preparation of technical documentation for regulatory submissions, ensuring data accuracy and compliance.
• Support inspection readiness activities, including assisting with audits and inspections as needed.
• Engage in continuous training and development to improve expertise in QC testing and regulatory compliance.

Qualifications:

• B.S. in Chemistry, Biology, Biochemistry, or a related scientific field.
• At least 4 years of experience in a GMP Quality Control function within the pharmaceutical/biotech industry, or equivalent relevant experience.
• Experience in method transfer, analytical method implementation, and lifecycle management.
• Strong technical writing skills, particularly in investigation documentation.
• Proficient in data analysis and interpretation with attention to detail.
• Strong problem-solving skills, including conducting investigations and implementing corrective actions (CAPA).
• Excellent organizational skills with the ability to manage multiple tasks autonomously.
• Effective communication and teamwork abilities to work collaboratively with cross-functional teams.
• Proficiency in LabWare LIMS, Microsoft Excel, Word, and PowerPoint is preferred.

Additional Information:

• Flexibility for weekend and occasional off-site responsibilities is required.
• Ability to participate in a continuous operational schedule, including weekend work, is essential.

Shifts: Friday, Saturday, Sunday and Monday

Seniority level: Mid-Senior level

Employment type: Contract

Job function: Quality Assurance

Industries: IT Services and IT Consulting