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QA Specialist - Level 1 US

Company: Yoh
Location: Waltham
Posted on: June 4, 2021

Job Description:

QA Specialist needed for a temporary contract opportunity with Yoh Scientific’s client located in Waltham, MA area.

This position is in the Quality Assurance Department of a major pharmaceutical company, and requires a BS or MS degree, 8+ years in the pharma industry with at least 3-5 years in quality roles, and experience and knowledge of small molecules chemistry, tablets and capsules.

Key Responsibilities:

Perform documentation review related to manufacturing and packaging of product such as executed batch records, deviations, CAPA deliverables and associated documents.
Support product batch disposition by conducting review of executed batch record; disposition documentation package preparation; review of deviations.
Accurately update/maintain batch trackers; lot genealogies; compliance trackers such as Quality alerts; Quality bulletin; KPIs, etc.
Manage/upload product disposition documentation in the controlled documentation system ensuring proper archival.
Clearly communicate issues as applicable to CMOs and Quality management in a timely basis Review and approve documentation related to production and / or packaging operations as assigned.
As appropriate attend project meetings.

Qualifications:

BS in science (Biology; Chemistry; Biotechnology; Pharmaceutical Science) Minimum of 8+ years of experience in pharmaceutical industry with at least 3-5 years in Quality (no rookies) Experience and working knowledge on Small molecules chemistry, tablets and capsules.
Experience building relationships and working with CMOs Working knowledge ICH/EMA/FDA regulations Competency in MS Office, Adobe Acrobat, Veeva, Trackwise

Opportunity is Calling, Apply Now!

Recruiter: Mary Nestojko, Mary.Nestojko@yoh.com

What’s In It For You?

We welcome you to be a part of one of the largest global staffing companies to meet your career aspirations. Yoh’s network of client companies has been employing professionals like you for over 65 years in the U.S., UK and Canada. Join Yoh’s extensive talent community that will provide you with access to Yoh’s vast network of opportunities and gain access to this exclusive opportunity available to you.

Medical, Dental & Vision Benefits 401K Retirement Saving Plan Life & Disability Insurance Direct Deposit & weekly ePayroll Employee Discount Programs Referral Bonus Programs

Yoh makes finding and applying for jobs simple. Partner with Yoh to find the right opportunities across multiple industries in the US and UK. Find out more here!

#CB-SA #Mon-SA #IND-SA

Yoh, a Day & Zimmermann company, is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran. Visit https://www.yoh.com/applicants-with-disabilities to contact us if you are an individual with a disability and require accommodation in the application process.

Keywords: Yoh, Waltham , QA Specialist - Level 1 US, Other , Waltham, Massachusetts

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