Quality Assurance Specialist (Contract) Details

Quality Assurance Specialist (Contract)

Translate Bio - Lexington, MA

Employment Type : Full-Time

Job SummaryJOB SUMMARY:
The Quality Assurance Specialist reports to the Associate Director and is an integral part of the Quality team. This position offers opportunities to focus on disposition of product for Translate Bio, inclusive of review and release of manufacturing/test documentation from process development, manufacturing and nonclinical, clinical and commercial processes and supply chains. This includes batch records, deviations, CAPAs, CoAs, CoCs, Job ResponsibilitiesPRINCIPAL DUTIES:

• Reviews and approves master production records for the timely initiation of GMP manufacturing activities.

• Reviews executed batch records and related documentation, resolves compliance issues and dispositions lots of drug substance, bulk drug product, 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/Review documentation, i.e. Deviations, CAPAs, OOS etc., as they occur.
• Write and revise SOP, forms, WI, and any other document types
• Assist with internal and external audits.
• Support of data analysis and metrics for QMR, KPIs, and other reportable forums may be requested.
• Assume additional responsibilities as assigned.

Required Skills & QualificationsJOB QUALIFICATIONS
1. Bachelor’s and/or 8+ years of relevant experience, Master’s preferred 2. Minimum 2 years of experience in Quality Assurance 3. 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.

• Must have excellent attention to detail, project and time management skills, and the 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.

WORK ENVIRONMENT AND PHYSICAL DEMANDS
Work is performed in an office environment with light physical demands and normal exposure to everyday risks and discomfort requiring common safety precautions. On occasion, travel to the manufacturing/test site(s) might be required.
This job description is intended to describe the general nature and level of the work being performed by employees in the position. It is not intended to be a complete list of all responsibilities, duties, and skills for the position. The Company reserves the right at all times, in