Manufacturing Associate III- Vaccines

Job description

Overview

 

GENERAL SUMMARY OF POSITION:

 

Manufactures, assembles, and labels clinical and commercial biologic products. Operates manual and semi-automatic equipment and automated production equipment. Perform all functions under cGMP guidelines.  

Responsibilities

MAJOR RESPONSIBILITIES:

  • Perform and may supervise manufacturing activities for a variety of clinical and commercial products which may include
  • bioreactor operation, purification, filling, packaging, and labeling
  • Perform manufacturing activities of licensed and clinical products in an aseptic environment
  • Perform autoclaving, cleaning and sterilization operations as needed.
  • Ensure maintenance of records and logbooks
  • Tabulate data and prepares reports
  • Train lower level personnel in manufacturing processes and ensures training records are up to date
  • Serve as department liaison with support departments such as compliance, facilities, engineering and quality groups
  • Review records/documents and ensures compliance with cGMPs
  • Write SOPs, batch records, technical reports and other cGMP documents as required
  • Ensure media, glassware and other required items are ready for production
  • Participates in incident deviations and remediation
  • Propose production schedules to meet production needs and coordinates schedules during shut-down periods
  • Make recommendations in improving and streamlining production operations
  • Manage on-site inventory for day to day operations
  • Perform visual inspection of final product vials
  • Perform additional job related duties as required
Qualifications

REQUIRED QUALIFICATIONS:

  • Requires a bachelor’s degree in a scientific discipline, preferably biology with a minimum
  • 5 years of relevant experience or equivalent
  • Ability to follow instructions precisely , recognize deviations, and recommend corrective action
  • Prior experience in a cGxP regulated environment. Strong working knowledge of CFR 21
  • Demonstrated ability to train and supervise others
  • Ability to conduct complex troubleshooting 
  • Computer literate and proficient in MS Word, Excel and other relevant electronic systems
  • Strong critical thinking, time management and organizational skills.  Demonstrated ability to multitask
  • and consistently meet deadlines
  • Possesses well developed attention to detail, ability to maintain accurate records and excellent proofreading skills.
  • Excellent written and verbal communication skills. Ability to communicate effectively (up, down, and laterally) with others 
  • Demonstrated initiative through past experience
  • Ability to work effectively both independently and as a member of a team
  • Experience in the following areas is required: aseptic manufacturing
  • Experience in the following areas preferred: aseptic filling, cell culture, purification
  • No travel required, standard work hours may require weekend and off shift hours as required / must be able to lift a minimum of 50 lbs using proper lifting technique

 

 

 

Diversity Profile: University

 

AAUP COMPENSATION SURVEY DATA

View more

Learn more on Inside Higher Ed's College Page for University

Arrow pointing right
Job No:
Posted: 10/14/2020
Application Due: 1/12/2021
Work Type:
Salary: