Senior Quality Assurance Associate

6 days ago


Waltham, Massachusetts, United States Mindlance Full time
Quality Assurance Associate III

**Job Summary**

Mindlance is seeking a highly skilled Quality Assurance Associate III to join our team.

**Key Responsibilities**

* Review executed batch records and related documentation, resolve compliance issues, and dispose of lots of drug substance, bulk drug product, and clinical materials for use in clinical trials.

* Perform lot release Quality Review of manufacturing and quality control records to ensure compliance with specifications and regulations.

* Ensure that all requirements, as stipulated in the appropriate QTA, have been met.

* Issue and review documentation, i.e. deviations, CAPAs, OOS, etc., as they occur.

* Write and revise SOPs, forms, WI, and other document types.

* Assist with internal and external audits.

* Support data analysis and metrics for QMR, KPIs, and other reportable forums.

**Requirements**

* Bachelor's and/or 8+ years of relevant experience.

* Minimum 5 years of experience in Quality Assurance, preferably with lot release experience.

* Working knowledge and ability to apply Quality principles and cGMPs in conformance to standards, preferably gained from working in a manufacturing, QA, or QC environment.

* Demonstrated ability to interact and communicate effectively, both written and verbal, with peers, management, auditors, and consultants.

* Excellent attention to detail, project and time management skills, and ability to manage multiple priorities with aggressive timelines.

* Preferred experience with outsourced manufacturing and testing operations.

* Working knowledge of MS Office products, including Word, Excel, Outlook, PowerPoint, and Project.

**Equal Opportunity Employer**

Mindlance is an Equal Opportunity Employer and does not discriminate in employment on the basis of Minority/Gender/Disability/Religion/LGBTQI/Age/Veterans.

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