Quality Assurance Associate
Pioneer Data
- Andover, MA
- Permanent
- Full-time
Our client, a world-leading Pharmaceutical Company in Andover, MA is currently looking for a Manufacturing Quality Associate to join their expanding team.Job Title: Manufacturing Quality Associate / Pharma Industry
Duration: 18 months contract, extendable up to 48 months
Location: Andover, MANote:
The client has the right-to-hire you as a permanent employee at any time during or after the end of the contract.
You may participate in the company group medical insurance planJob Description (Required)Quality Assurance AssociateSummary:
You will be a member of client's dedicated and highly effective quality assurance team.
You will be responsible for providing Quality Assurance support to GMP clinical manufacturing.
You will make sure that product and process documents match the specifications based on established sampling and statistical process control procedures.
Your expertise will help in identifying deviations from established standards in the manufacturing and packaging of products.
In the relevant cases, you will approve investigations to ensure compliance.As an associate, your knowledge and skills will contribute to the goals and objectives of the team. Your focus and ability to meet team targets will help in completing critical deliverables.
Your innovative use of communication tools and techniques will facilitate in explaining issues and create a collaborative team environment.It is your hard work and commitment that will make Client ready to achieve new milestones and help patients across the globe.Responsibilities:
Support Quality validation activities for both laboratory (Analytical Research and Development) and manufacturing facility (Bioprocess Research and Development/ Pharmaceutical Research and Development) equipment/instruments at the Andover site
Contribute to the completion of complex projects, manage own time to meet agreed targets and develop plans for work activities on own projects within a team
Review and approve various Good Manufacturing Practices {also cGMP} records (primarily batch records) and investigations
Ensure that all documents for batch release are reviewed for completeness and accuracy
Make quality decisions to resolve moderately complex issues with assistance from management
Seek out and assess internal and external compliance with applicable regulations
Support the site relative to a constant state of inspection readiness. Participate in audits relative to this role as needed
Recognize when an issue is beyond your sphere of influence and escalate immediately
Participate in Limited Duration Teams, Right First Time (RFT) Improvement projects, Corrective Action / Preventive Action Effectiveness, etc. as appropriate
Assist and support the manufacturing staff in detecting and solving compliance errors in real time during manufacturing operations
Help to define appropriate action plans for improvement and follow-up and communicate action closures
May participate in the release of raw materials, as neededQualifications:
Bachelor's degree in a related field
A minimum of 1-2 years of experience in a related role
Knowledge of current Good Manufacturing Practices and the applicable GxP regulations and standards
Experience at a manufacturing site preferred
Experience writing and managing deviations
Experience in production batch record review, Enterprise Resource Planning systems, investigation of non-conformance, root cause analysis, and change control management is preferredLocation/Schedule:
This is a fully onsite role in Andover, MA
Monday - Friday; 40 hours per week