QC Manager, Chemistry

Devens, Massachusetts
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Type: Direct-Hire

Category: Scientific & Clinical

Job ID: 132953

Date Posted: 03/15/2019


Job Title: QC Lab Manager
Address: Harvard, MA

 

Responsibilities:
1. Manage QC team, consisting of 2 direct reports and their teams to ensure staff development, support for manufacturing and GMP compliance.
2. Provides leadership to the group through effective communication, coaching, training, development, and ensures staff acts in accordance with company policies and practices with respect to GMP, safety, and other related regulatory requirements.
3. Participates in deviation and OOS investigations.
4. Develops, improves, and revises SOPs, test methods, and other GMP documentation as needed.
 

Requirements:
1. BS in Chemistry or equivalent

2. 5+ years experience in a QC or Pharmaceutical laboratory environment  
3.  Experience managing direct reports required. 
4. Strong technical writing skills and the ability to clearly express ideas in English
5. Strong working knowledge of organic analytical chemistry techniques.
6.  Extensive knowledge in FDA regulations, ICH Q7, GMPs, and Quality Systems.
7. Experience with Microsoft Office and other complex computer software 

8. Ability to commute to Harvard, MA or relocate (relocation package included). 


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