QA Associate

Fall River, MA 02720

Employment Type: Permanent Job Number: 53967188 Pay Rate: $67000-95000 / year Specialty: Branch: Pay Type:

Job Description

Job Title
QA Associate
Job Details
QA Associate – Full-Time, Exempt Professional
Salary Range: $67,000 – $95,000
Job Location
Fall River, MA
Work Hours
General hours: 8:00 AM – 5:00 PM (may vary based on business needs)
Reports To
Site Quality Assurance Head
Position Purpose
The purpose of the QA Associate position is to accurately review the chronological record of Laboratory Instrument and Equipment electronic data–related activities, ensuring documented evidence of relevant details for specific events while supporting data integrity and cGMP compliance.
Duties and Responsibilities: include the following. Other duties may be assigned.
  • Function as Subject Matter Expert (SME) for Quality-related activities within QMS platforms and other electronic systems requiring compliance with 21 CFR Part 11
  • Monitor and review electronic records, audit trails, and critical parameter changes that could impact product quality
  • Conduct regular audit trail reviews to identify irregularities, trends, or potential compliance risks
  • Analyze electronic data proactively to identify opportunities for continuous improvement
  • Provide comprehensive training to laboratory and manufacturing personnel utilizing digital platforms for GMP/GLP execution
  • Ensure users understand audit trail integrity, data integrity principles, and their role in maintaining compliant electronic records
  • Support investigations and implementation of deviations, investigations, and CAPAs related to electronic data and system findings
  • Collaborate with Quality, Laboratory, and Manufacturing teams to maintain compliance and data integrity
Qualifications
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily.
Education & Experience
  • Bachelor of Science degree in a scientific discipline related to the pharmaceutical industry (Biology, Chemistry, Pharmacology, Biochemistry, or related field)
  • Minimum of two (2) years of Quality Assurance experience in a GMP pharmaceutical manufacturing environment supporting Quality Control Laboratory and Manufacturing operations
  • Basic knowledge and industry experience with quality systems related to electronic records storage, retrieval, archival, and audit of electronic data
  • Experience with MDI or DPI dosage form manufacturing preferred
Knowledge, Skills, and Abilities
  • Strong aptitude for quantitative problem-solving and data analysis
  • Ability to multitask, prioritize effectively, and manage time in a regulated environment
  • Strong database and computer skills with experience analyzing and reviewing complex data
  • Advanced proficiency with Microsoft Excel
  • Strong working knowledge of current Good Manufacturing Practices (cGMP)
  • Exceptional attention to detail and documentation accuracy
  • Self-starter with initiative and accountability
  • Strong written and verbal communication skills
Other Job Information
  • Relocation assistance may be negotiable
  • No remote work available
  • No employment sponsorship available
Company Overview
Founded in 2010, Top Prospect Group was created with a focus on matching high-quality candidates with top clients while fostering an environment where success is shared by all. In 2023, the company was acquired by HW Staffing Solutions, expanding its service offerings to include technology and professional services.
Qualified candidates are encouraged to apply immediately!
Please include a clean copy of your resume, salary expectations, and any references in your application.
#INDTPGSHELTON

Additional Information

At HW Staffing Solutions we recognize the value of our employee associates as equally as our clients. We are passionate about people and improving the lives of every associate, we do this by connecting you with great companies and great opportunities. We celebrate our awesome diversity, believe that everyone has a unique talent, and appreciate the passion and perspectives that each of us bring to the table. Discover a new way to work together with a company that is focused on offering the best opportunities, benefits and career advancement in Accounting & Finance, Office & Administrative, Light Industrial, Professional & Technical, Call Center, Food Processing and Hospitality. HW Staffing Solutions is an Equal Employment Opportunity company.

Meet Your Recruiter

Daniel Dubay

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About Fall River, MA

Ready to take your career to the next level in Fall River, Massachusetts? Explore our job opportunities in this vibrant city known for its rich history, stunning waterfront views, and amazing growth potential. With easy access to Boston and Providence, Fall River offers a perfect blend of small-town charm and big-city opportunities. Indulge in delicious Portuguese cuisine, stroll along Battleship Cove, catch a show at the Narrows Center for the Arts, or enjoy the eclectic boutiques of the historic downtown area. Join us in Fall River to discover a career destination that combines a thriving job market with a captivating cultural scene to create the perfect work-life balance!