Overview
Quality Control Analyst Jobs in Massachusetts, United States at Barrington James
Title: Quality Control Analyst
Company: Barrington James
Location: Massachusetts, United States
Job Title: Quality Assurance Specialist
Location: Fall River, MA
Position Overview:
We are seeking a detail-oriented and proactive Quality Assurance Specialist to join a dynamic team in ensuring the highest standards of quality in pharmaceutical manufacturing processes. This is an individual contributor role responsible for ensuring compliance with regulatory standards, maintaining process controls, and supporting the overall quality systems within the organization.
Key Responsibilities:
Review and ensure compliance of method validation/verification protocols and related study reports.
Monitor and enforce adherence to Good Laboratory Practices (cGLP) in laboratory operations.
Verify standard operating procedures (SOPs) and test procedures for accuracy and compliance.
Coordinate with cross-functional teams, including Regulatory Affairs, to submit required documents for abbreviated new drug applications (ANDAs).
Maintain proper tracking, recording, and archival of all incoming documents.
Identify system gaps and work with management to implement improvements.
Participate in investigations and ensure compliance with regulatory standards during incidents.
Conduct internal audits in the analytical lab to ensure compliance.
Implement updates to the Pharmacopoeia as needed, ensuring the use of the latest editions, supplements, and amendments.
Assist with departmental and cross-functional projects as needed.
Qualifications:
Bachelor’s degree in Chemistry, Pharmaceutical Sciences, or a related field (Master’s degree preferred).
Strong knowledge of Good Laboratory Practices (cGLP), Good Manufacturing Practices (GMP), and Good Distribution Practices (GDP).
Experience in analytical laboratory activities, including API and drug product testing.
Proficiency in Microsoft Office and Quality Assurance applications.
Experience with SAP or similar business systems is a plus.
Familiarity with Inhalation products (MDI) is a plus.
Ability to manage compliance and regulatory audits at both local and federal levels.
Strong documentation and technical writing skills.
Skills and Competencies:
Strong analytical and problem-solving abilities.
Excellent communication skills, both written and verbal.
Self-motivated with the ability to work independently and in a team environment.
Strong organisational skills with a focus on detail and quality.
Ability to work in a fast-paced, dynamic environment and meet deadlines.
Additional Information:
This role requires working in a pharmaceutical manufacturing environment with appropriate personal protective equipment (PPE).
