Quality Control Technical Services Analyst IV

Norton, MA

$60–$68 Per Hour
Instant Apply

3 days ago

Job Description

Title: Quality Control Technical Services Analyst IV
Location: Norton, MA- Hybrid
Duration: 12 months+
Pay: $60/hr. - $68/hr. on w2

Overview:

The Quality Control Technical Services (QCTS) Analyst IV plays a crucial role in supporting the department's efforts to maintain the highest standards of quality and compliance from development through to commercialization. In addition to active participation in stability studies, data trending, and investigations, this position will provide technical specification support and will assist in facilitating method transfers and implementation. By ensuring these critical activities are executed with precision, the Analyst IV significantly contributes to routine laboratory operations, thereby enhancing the overall efficiency and effectiveness of the QC functions.

This position is hybrid role in Norton, MA with responsibility at both locations (Cambridge and Norton).

Key Responsibilities (including but not limited to):

Provide robust support in the justification of technical specifications for raw materials, intermediates, and finished products, ensuring they meet all quality and compliance requirements.
Facilitate the transfer and implementation of analytical methods from development to routine use within the QC laboratory, including method validation and training of laboratory personnel.
Assist in the execution and documentation of stability studies, contributing to product shelf-life determinations and ensuring compliance with regulatory requirements.
Engage in the collection, analysis, and trending of QC data to identify and address potential quality issues, using statistical tools to ensure continuous product quality monitoring.
Support and sometimes lead investigations into analytical and product-related quality deviations, employing root cause analysis and implementing corrective and preventive actions (CAPAs) to mitigate risks and enhance quality.
Review routine and non-routine QC testing, ensuring the reliability and accuracy of results according to policies, procedures, and regulations.
Assist in preparing and reviewing technical documentation for regulatory submissions and audits, ensuring accuracy and compliance with global regulatory standards.
Actively participate in continuous improvement initiatives aimed at enhancing QC processes and procedures, increasing laboratory efficiency and effectiveness.
Actively represent Quality Control at cross-functional forums, including CMC meetings, ensuring QC perspectives and requirements are effectively communicated.
Collaborate with other organizational functions, including CMC Development, Manufacturing, Manufacturing Technical Services, Supply Chain, Regulatory, and Quality Assurance to ensure alignment with overall business goals.

Qualifications:

B.S. in chemistry, biology, or biochemistry, or related scientific field; advanced degrees considered;
Pharmaceutical/Biotech industry experience with 8-12 years in a GMP Quality Control function or equivalent, relevant industry experience
Experience in technical specification development, method transfer, and/or analytical method implementation
Proficient in data analysis and interpretation, with excellent attention to detail
Solid problem-solving skills and experience in conducting investigations and implementing CAPA
Strong organizational skills with the ability to manage multiple tasks simultaneously and autonomously
Excellent communication and teamwork abilities, capable of working effectively in a collaborative environment
Proficiency in LabWare LIMS, Excel, Word, and PowerPoint preferred

Numbers & Facts

Location	Norton, MA
Salary	$60–$68 Per Hour

Skills

Analysis Skillsunmatched
Analytical Method Developmentunmatched
Biochemistryunmatched
Biologyunmatched
Biotech and Pharmaceuticalunmatched
Chemistryunmatched
Communication Skillsunmatched
Continuous Improvementunmatched
Corrective Actionunmatched
Corrective and Preventative Action (CAPA) Systemsunmatched
Cross-Functionalunmatched
Data Analysisunmatched
Detail Orientedunmatched
Documentationunmatched
GMP (Good Manufacturing Practices)unmatched
Insurance Regulationsunmatched
Laboratory Information Management System (LIMS)unmatched
Laboratory Operationsunmatched
Labwareunmatched
Maintain Complianceunmatched
Manufacturingunmatched
Manufacturing Technologyunmatched
Microsoft Excelunmatched
Microsoft PowerPointunmatched
Microsoft Wordunmatched
Multitaskingunmatched
Organizational Skillsunmatched
Problem Solving Skillsunmatched
Quality Assuranceunmatched
Quality Controlunmatched
Quality Monitoringunmatched
Regulationsunmatched
Regulatory Complianceunmatched
Regulatory Requirementsunmatched
Regulatory Submissionsunmatched
Requirements Managementunmatched
Risk Managementunmatched
Root Cause Analysisunmatched
Staff Trainingunmatched
Supply Chainunmatched
Team Playerunmatched
Technical Supportunmatched
Technical Writingunmatched
Testingunmatched
Trend Analysisunmatched

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