Manufacturing Compliance Specialist - Cambridge, MA | Biospace
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Manufacturing Compliance Specialist

WAVE Life Sciences

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Location:
Cambridge, MA
Posted Date:
11/16/2016
Position Type:
Full time
Job Code:
Salary:
Required Education:
Bachelors Degree
Areas of Expertise Desired:

Job Description

The Project Support Specialist writes, issues, maintains and follows batch records lifecycle throughout the manufacturing plant. Once documents have been created and approved, the incumbent will be responsible for tracking the lifecycle of batch records and documents to support manufacturing activities.   This position also writes and reviews standard operating procedures (SOPs).

Responsibilities:

May include some or all of the following:
•   Responsible for creating documentation including batch records, SOPs, logbooks, etc. that will be used throughout the manufacturing facility
•   Adheres to internal/external guidelines, specifications, and regulatory requirements while creating and maintaining documentation
•   Ensures that SOPs relevant to documentation (batch records, logbooks, etc.) are generated, maintained and available
•   Tracks GMP review and production close out of batch record documentation
•   Key contact with Quality Assurance to ensure robust and stable document flow from issuance to archiving
•   Positively interacts with internal associates to quickly and effectively resolve issues
•   Addresses deficiencies and ensures completion of all follow-up actions, specifically those that target process fixes to maintain consistent resolutions to all batch review issues according to GMP standards and company objectives
•   Supports implementation of CAPAs, SOP revisions, quality improvement initiatives, operational excellence projects, etc.
•   Develops processes for batch records including for issuing, tracking and reviewing batch records  
•   Develops and maintains metrics to track batch record turnaround time, errors and document related deviations

Requirements

Education / Experience:
•   Bachelor’s degree in chemistry, science or engineering or equivalent work experience
•   4+ years of broad cGMP production experience, with knowledge and understanding of process, documentation requirements and activities, preferably in an oligonucleotide manufacturing environment
•   Extensive experience with GMP documentation management

Skills / Pre-requisites:
•   Strong attention to detail and excellent organizational skills
•   Exceptional written and verbal communication skills
•   Ability to work effectively in a team environment
•   Thorough knowledge of Microsoft Office Suite