Biotech Production Compliance Coordinator (Mid Scale Manufacturing)

Location
Rensselaer, New York
Posted
Jan 27, 2022
Ref
REGEA0026R4869
Required Education
Associate Degree
Position Type
Full time

Summary:  Performs all compliance related administrative tasks necessary for supporting commercial manufacturing operations.

Essential Duties and Responsibilities include, but are not limited to, the following:
•Independently prepares all compliance documentation required to implement corrective actions and changes to various GMP processes in support of manufacturing operations, and in accordance with cGMP standards and written procedures
•Analyzes and evaluates information gathered through cross functional interactions and presents findings and recommendations at group meetings
•Reviews completed batch records and logbooks in accordance with cGMP standards to ensure compliance with written procedure
•Reviews, edits, and revises controlled documents (batch records, logbooks, SOPs, etc.) in accordance with cGMP standards to ensure compliance with written procedures
•Monitors production processes to obtain necessary data in support of investigations and track effectiveness of changes
•Participates in and/or leads cross-functional study teams to support investigations and author change controls
•Gathers, trends, and analyzes process related data to drive consistency and timeliness
•Documents all training
•Assists with training of new employees
•Ensures all tasks are performed in a manner consistent with safety standards

Education and Experience:
Level II: Bachelor’s degree, preferably in Life Sciences or a related field, or
AS/AAS Degree in Biotechnology/Biological Science and 0-2 years of relevant work experience
Level III: Requires BS/BA in Life Sciences, or related field and 2 years of
relevant experience or equivalent combination of education and experience
Sr Level: Requires BS/BA in Life Sciences, or related field and 5 years of
relevant experience or equivalent combination of education and experience

Title level is based on education and experience