Quality Assurance Manager

Sanofi Pasteur is the vaccines division of the sanofi-aventis Group. As the vaccines division of the sanofi-aventis Group, sanofi pasteur is devoted exclusively to the research, production, and worldwide distribution of human vaccines. To date, our wide range of vaccines provides protection against 20 bacterial and viral diseases around the world. We distribute more than a billion doses of vaccine each year, making it possible to vaccinate more than 500 million people across the globe. Our Worldwide Headquarters is located in Lyon, France, and we have a global presence across 150 countries.

Acambis Campus, part of the sanofi pasteur company, is a leading vaccine company developing novel vaccines that address significant unmet medical needs or substantially improve standards of care.  The Acambis Campus is recognised internationally as the leading producer of smallpox vaccines for emergency-use stockpiles held by the US Government and several other governments around the world. Acambis developed its ACAM2000™ smallpox vaccine under contracts with the US Government.

We are looking for a Quality Assurance Associate to perform QA functions supporting fill/finish operations, which include component inspection/release, batch record preparation, print and issue labeling, verifying room and equipment compliance, document audits and finished goods release.  Write and revise SOP’s and related manufacturing documentation.  Investigate all manufacturing and laboratory discrepancies in conjunction with the Company’s manufacturing facility including investigations associated with incident reports, out-of-specification results, etc

• Prepare batch records for issuance in a timely matter.
• Inspect fill/finish manufacturing area before, during and after operation.
• Perform room clearance review and disposition.
• Perform batch record review and release in a timely matter.
• Perform verification of room and equipment cleaning and maintenance logs as required by SOP's.
• Assist in operation of the label room including printing, counting, inspecting and approving labels and inventory control as required.
• Issue labeling and receive returned labeling.
• Represents Quality Assurance on all GXP compliance issues.
• Gathers trending and reporting of applicable data.
• Conducts facility oriented Quality Investigations and reviews and proposes Corrective Actions according to approved procedures and GXP guidelines.  Investigations include but are not limited to raw materials and finished products.
• Reviews datasheets, log sheets, batch records, SOP’s, Technical reports, and deviation reports as needed
  Performs other duties as requested

The right individual needs a BS in a Biology Science/Microbiology/Biotechnology with 4 years of Quality Assurance experience in a pharmaceutical/biotechnology industry, or a minimum of 2 years experience as Quality Assurance in Fill/Finish operations. Practical knowledge of FDA’s current good Manufacturing Practices (cGMP) as well as good knowledge of the Environmental Monitoring systems is a must. Ability to read, interpret and execute requirements of standards such as ANSI/ASQ Z1.4, as well as Standard Operating Procedures, Master Production Control Documents, Component Specifications, safety guidelines and company policies are required. The individual must have basic computer skills including Microsoft Word, Excel, PowerPoint and Outlook.  Must be able to work independently, prioritize and exhibit attention to details and with flexible hours.

CONTACT INFO:

Human Resources

sanofi pasteur, Acambis Campus

38 Sidney Street

Cambridge, MA  02139

E-mail: [Click Here to Email Your Resumé]

Interested applicants must apply on-line attaching a word document to your email submission

Acambis Inc. provides a competitive salary and a full range of benefits.

We are proud to be an equal opportunity employer, dedicated to promoting a culturally diverse workplace.