Quality Assurance Auditor

Company: SARTORIUS STED BIO
Location: Cambridge
Posted on: May 3, 2021

Job Description:

We are currently seeking a detail oriented Quality Assurance Auditor with a passion for QA to join our outstanding team of professionals. You will administer Quality systems using your knowledge of basic skills, procedures, methods and techniques along with applicable good manufacturing practices. You will be a key contributor in helping to ensure implementation, maintenance, and improvement of Quality system.

Main Responsibilities & Tasks:

• Perform monthly audits on systems, processes, facilities, suppliers within a GxP environment
• Review and approval of Certificates of Analysis, Final Reports, Master Documents
• Review and approval of documents produced by operations when conducting GMP work (raw data, electronic data, laboratory assays related to client studies)
• Follow through on corrective and preventative actions from deviations and audit observations
• Trend and track audits and CAPAs for Quality Review Board meetings
• Receipt of new equipment into Quality systems
• Receipt of raw materials or Client samples against their specifications as needed
• May be cross trained to perform mastering, issuance, reconciliation, archiving of internal documents
• Assist with training of new hires
• Write, review, and/or approve Standard Operating Procedures (SOPs)
• Assist with Client or Regulatory audits and tours
• Support ongoing process improvement endeavors
• Work collaboratively with staff responding to and resolving deviations and incidents
• Other assignments as delegated

Qualifications & Skills:

• Associate's degree preferably in a scientific disciplline (Bachelor's degree is preferred)
• Minimum of 2 years of experience in a GxP environment
• Minimum of 2 years' experience in auditing
• Ability to work independently with strong attention to detail
• Efficient organizational skills, with the ability to effectively multitask
• Knowledge of requirements and relevant industry standard practices is preferable along with a demonstrated ability to interpret regulations to ensure proper implementation in the quality systems
• Good communications skills (written and verbal),
• Ability to at times navigate challenging business situations during the coordination of QMS programs
• Ability to assess assigned task requirements, identify potential challenges, and communicate effectively to expedite successful execution of work
• Working knowledge of Microsoft Word, Excel and Outlook
• Friendly attitude and a passion to excel
• Alignment with our core values of: Openness, Sustainability and Enjoyment

Driving our future growth requires talented people. Sartorius is a dynamic organization suited to people who want to showcase skills, be recognized for expertise and thrive in a vibrant and innovative environment.

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex or national origin. We are also an equal opportunity employer of individuals with disabilities and protected veterans.

Please view equal employment opportunity posters provided by OFCCP here

E-Verify Participation Info

E-Verify Workers Rights

Sartorius is an Equal Opportunity/Affirmative Action employer and will consider all qualified applicants for employment without regard to race, color, religion, gender, sexual orientation, gender identity, national origin, age, protected veteran status, or disability status.

All employment decisions are based on valid job-related requirements.

If you are a qualified individual with a disability or a disabled veteran and are unable or limited in your ability to use or access our website, you may request a reasonable accommodation to express interest in a specific opening. You can request reasonable accommodation by calling +1 631 254 4249 ext 8330 or via e-mail at accommodationrequest@sartorius.com

We look for employees who would like to grow with us and move the innovative life sciences sector forward. In the process, we focus on agile project work, mutual support within teams and working as equals. Sartorius thrives as a company with people who give their very best every day and who are eager to develop personally and professionally.

Further insights into our world of work can be found here.

Keywords: SARTORIUS STED BIO, Cambridge , Quality Assurance Auditor, Other , Cambridge, Massachusetts