Quality Analyst

Job Title: Quality Analyst I

Job Type: Full Time, Exempt Professional

Location: Fall River, MA (Onsite)

Work Hours: General Shift – 8:30 AM to 5:00 PM

Position Overview

The Quality Analyst I monitors and ensures that product quality is maintained throughout all phases of the manufacturing process in compliance with established specifications, SOPs, and regulatory requirements. This is an individual contributor role within the Quality Assurance team, reporting to the Quality Assurance Manager. The role includes in-process testing, equipment checks, batch record assessments, and various other quality assurance duties to ensure the production of high-quality pharmaceutical products.

Key Responsibilities

• Perform in-process testing (e.g., weight, thickness, hardness, disintegration, friability) per batch record instructions.
• Conduct room and equipment checks at each stage of manufacturing, following detailed procedures.
• Execute Acceptable Quality Limit (AQL) sampling and inspections as required.
• Inspect in-process and finished product samples and document results for the Quality Control Lab.
• Maintain standard weight records and perform daily verification of balances.
• Isolate rejected materials during batch processes and ensure proper documentation.
• Monitor facility and environmental operating conditions, including temperature, humidity, and pest control.
• Review engineering records such as calibration, PM, and pest control records.
• Assess and verify online batch records for completeness, signatures, and yield reconciliation.
• Perform applicable testing for customer complaints and report findings.
• Identify and report any non-conformances or discrepancies to management.
• Participate in additional tasks or project work as assigned.
  
  

Qualifications

• Education/Training: Advanced vocational training or education in pharmaceutical manufacturing, industrial management, or a related field preferred.
• Experience: Minimum of 3 years' experience in Quality Assurance in a GMP pharmaceutical manufacturing environment.
• Skills:
• Experience with MDI or parentals preferred.
• Strong knowledge of cGMP and regulatory requirements.
• Attention to detail and strong organizational skills.
• Ability to follow detailed procedures and document results accurately.
• Proficient in Microsoft Office and other business applications.
• Strong interpersonal and communication skills (written and verbal).
  

Nice To Have

• Experience with MDI (Metered Dose Inhalation) products.
  
  

Additional Information

• Work Hours: General Shift: 8:30 AM – 5:00 PM (may vary based on business needs).
• Physical Demands: Ability to work in a pharmaceutical manufacturing environment and wear necessary personal protective equipment (PPE) when required.
• Work Environment: Must be able to function in a clean room environment adhering to strict regulatory guidelines.
  
  

Skills: communication skills,cgmp,quality assurance,regulatory requirements,organizational skills,manufacturing,records,microsoft office,checks,testing,attention to detail,mdi,interpersonal skills,pharmaceutical manufacturing,general,management