24 days old

Quality Assurance Specialist

Kelly Services
Albany, NY 12260
Kelly Science is seeking a **Quality Assurance Specialist** for a growing biopharmaceutical company located in **Albany, NY** .

**Shift:** Monday-Friday 7:00am 3:30pm

**Employment Type:** Full Time; Direct Hire


The Quality Assurance Specialist will be responsible for the oversight of the quality assurance program and the quality management system at the site level.

**Job duties may include:**

+ Maintain oversight of the QA program and Quality Management System (QMS)

+ Apply quality assurance processes and procedures at the site level to ensure product quality and regulatory compliance.

+ Write, review, approve, and implement procedures, specifications, processes, and methods as required.

+ Oversee the examination and evaluation of each lot of incoming material

+ Ensure that personnel is properly trained and qualified. Ensure that the training is documented.

+ Conduct periodic audits of the site to monitor compliance with established procedures and practices. May infrequently audit another site.

+ Oversee the metrology program at the site (i.e., equipment, personnel qualifications, validations, etc.).

+ Ensure manufacturing and analytical equipment is appropriately maintained and calibrated.

+ Review trends (e.g., environmental monitoring, deviations, facility issues, etc.) to initiate corrective and preventive actions and/or for continuous process improvement.

+ Conduct a continuous review of aseptic operations to ensure compliance to internal procedures (e.g. gowning, cleaning, sanitation, sterility, environmental monitoring, etc.) and USP/FDA regulations.

+ Ensure an investigation is performed and documented when required, and corrective and preventative actions are taken (i.e., follow and maintain corporate CAPA, deviation, and OOS protocols).

+ Ensure compliance with all applicable standard operating procedures and regulations, including 21 CFR Part 212 (and 211 as needed) requirements.

+ Other duties as assigned


+ Bachelors Degree in a science related field

+ 2-3 years of relevant quality assurance experience

+ Experience and/or full knowledge of manufacturing operations, preparation of sterile injectables, aseptic processing, and distribution of aseptic products preferred.

+ Knowledge of USP, FDA, and cGMP regulations preferred.

Interested? Apply today for immediate consideration!

**You should know:** Your safety matters! Vaccination against COVID-19 may be a requirement for this job in compliance with current client and governmental policies. A Kelly recruiter will confirm and share more details with you during the interview process.

**Why Kelly** **** **?**

Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire talented people just like you. Every day, we match science professionals with dream jobs that fit their skills and interestsits the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background/education in science, so we know a thing or two about the science market and how to get you noticed.

**About Kelly** ****

At Kelly, were always thinking about whats next and advising job seekers on new ways of working to reach their full potential. In fact, were a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live (plus, did we mention we provide a ton of benefits ?). Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.

Kelly is an equal opportunity employer committed to employing a diverse workforce, including, but not limited to, minorities, females, individuals with disabilities, protected veterans, sexual orientation, gender identity. Equal Employment Opportunity is The Law. (


Posted: 2022-07-25 Expires: 2022-08-25

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Quality Assurance Specialist

Kelly Services
Albany, NY 12260

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