ACCELERON PHARMA INC Quality Assurance Specialist III Salary in the United States

What’s in it for you?

Provide QA support and oversight of manufacturing operations, ensuring that all standards are observed. Review Manufacturing batch records in accordance with current Good Manufacturing Practices (cGMP), ensuring accurate and timely maintenance of manufacturing batch record documentation. Assist with Quality Control operations through review and approval of applicable documents. Perform quality processes in accordance with written procedures.

 What will you be doing?

• Perform batch record review and lot disposition activities for intermediates, drug substance and drug product
• Identify and resolve quality events using quality decision making with risk-based approach
• Review SOPs, logbooks, and other documentation related to daily QA activities
• Ensure quality and consistency in documentation and adherence to SOPs
• Perform Line Clearances for cGMP processes
• Perform internal audits of cGMP operations
• Develop and implement enhancements to quality system procedure
• Work closely to with Manufacturing and QC department to provide ongoing Quality support
• Other duties as assigned
• Partners with Technical Operations, QC, Regulatory, Supply chain, etc, to ensure alignment with Manufacturing and support functions in executing the quality strategy.

What are we looking for?

• An energetic professional with fundamental knowledge of FDA, ICH, and EU GxP Regulations and Guidelines.
• A team player with a willingness to collaborate within QA and cross functionally on projects as needed
• Ability to prioritize, plan, and complete work with minimal manager support; ability to communicate details to manager effectively gaining support & alignment.
• Effective open and direct communication skills recognized internally and externally; Ability to influence at the peer level.
• Strong sense of accountability & ownership of activities. Demonstrates problem solving ability and attention to detail. Ability to identify, propose, implement improvements internal to QA procedures and complete routine work independently.
• Experience with Veeva a plus.
• 3-5 years of experience with Bachelor’s degree in related field; 1-3 years of experience with Masters in related field (prefer scientific discipline)

How will you grow with us?

You will become an essential part of a team that helps drive a culture of quality.  A team that is collaborative, provides guidance and promotes autonomy.  You’ll have opportunity to gain a deeper understanding of QA Operation’s role in bringing a drug to market.

*In compliance with federal law, all persons hired will be required to verify identity and eligibility to work in the United States and complete the required employment eligibility verification document form upon hire.

*Recruiters - please do not send unsolicited resumes to this posting.

FOR IMMEDIATE CONSIDERATION PLEASE SUBMIT YOUR RESUME TO:

www.acceleronpharma.com