Quality Assurance Generalist

About the job

Job Summary:
The Quality Assurance Generalist is a entry level position responsible for quality assurance activities associated with cGMP manufacturing and documentation. Ensures that proper controls are followed and maintained during the manufacturing, processing, packaging, and warehousing of compounded products.

Key Responsibilities
• Support execution of product Batch Records and associated manufacturing and Quality related systems for the compounding processes.
• Ensure day-to-day compliance to all requirements established for compounded product and the systems supporting compounding.
• Assist with problem identification and resolution efforts for quality related issues associated with the compounding operations.
• Review and approve manufacturing batch records, labels and other batch related documentation.
• Assist with internal, corporate, 3rd party and federal/state inspections and audits.
• Provide contributing information on measures of local quality system effectiveness such as right the first time, documentation errors and others as assigned.
• Participate in QA meetings for Product manufacturing and Media Fill execution.
• Ensure cGMP documentation associated with work activities is complete.
• Maintain assigned standard operating procedures.
• Perform other related duties as assigned.

Set yourself apart

Basic Qualifications
• College Degree or a High school diploma or equivalent with cGMP experience in a pharmaceutical manufacturing company (or similar) required.
• Experience with aseptic technique, cGMP document review and MasterControl preferred.
• Proficient in MS Office programs, including Word and Excel.
• Ability to work in a fast-paced environment.
• Ability to handle a high volume of work and rapidly adapt to changing environment.

Core Competencies
• Ability to work with others in a positive and professional manner and to develop and maintain strong working relationships with co-workers and management.
• Ability to take initiative, including asking for and offering help when needed; performs work independently without being prompted.
• Strong attention to detail and focus on quality, accuracy, and accountability.

What’s on offer?

Our Benefits

We believe in our people and foster a supportive environment that develops and rewards performance and incentivizes long-term career success. Our benefits include, but are not limited to:
• Competitive Salary
• Health, Vision, and Dental Insurance
• Company Paid Life Insurance
• Generous Paid Holidays
• Paid Volunteer Time
• Generous Paid Time Off and Rollover
• Company matching 401K and Retirement Savings Plans
• Employee Assistance Program
• Flexible working arrangements Now let's not forget our site!

The FSS Boston facility is in beautiful Canton, Massachusetts. Employees enjoy ample parking at a state-of-the-art compounding facility. The employee breakroom provides plenty of storage for lunches and you can enjoy free coffee anytime of the day!
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