Manufacturing Associate Job at Insight Global, Durham, NC

Wkxud2ttSzY2QkdoaVUxK1lQQ2NsTkJUaXc9PQ==
  • Insight Global
  • Durham, NC

Job Description

Must Haves:

  • Bachelor’s degree in a related scientific or engineering discipline and 0-2 years’ experience in related cGMP manufacturing operations; or high school degree and 3-5 years’ experience, or equivalent.
  • Excellent written and verbal communication skills are required.
  • Energetic, motivated, and dynamic individual
  • Must be organized and able to focus in a fast-paced, multi-tasked environment and maintain operational efficiency and positive demeanor.

Pluses:

  • Basic knowledge of upstream (cell culture or fermentation), downstream (purification and bulk filling) or manufacturing support unit operations
  • Experience in single-use technology platform

Job Description:

Insight Global is seeking Manufacturing Associates in the Raleigh/Durham area for a large biopharmaceutical client. The Manufacturing Associate will be responsible for upstream unit operations (seed expansion, bioreactor operations, cell culture harvest), downstream unit operations (chromatography, tangential flow filtration, viral inactivation, and bulk filling) and/or manufacturing support operations (solution preparation, assembly preparation, parts wash, and autoclave) activities. Following task execution, the Manufacturing Associate will review the executed production records and logbooks to ensure GxP compliance.

Responsibilities:

  • Manufacture bulk intermediates and drug substances per manufacturing batch records and in compliance with quality standards, company policies and current regulations.
  • Perform operations in a cleanroom environment, applying controls to ensure aseptic processing including gowning and cleaning procedures.
  • Document each task involving manufacturing records and logbooks following GDP at the time of execution.
  • Utilize and perform maintenance on equipment per applicable SOP.
  • Ensure all materials are issued and accounted for during the execution of a record (i.e. SR, EPR and BR).
  • Demonstrate, apply, and ensure understanding of cGMP and how it applies to specific tasks and responsibilities.
  • Participate and be accountable for workplace organization (5S).

Shift: 7pm - 7am, 2-2-3 schedule

Job Tags

Shift work,

Similar Jobs

Diamond Peak Recruiting

Construction Superintendent - Commercial Projects Job at Diamond Peak Recruiting

 ...Monica area is seeking an experienced Construction Superintendent to oversee field operations...  ...Qualifications: ~5+ years of experience as a Superintendent on commercial projects...  ...of Santa Monica and Westside commercial work Competitive compensation with performance... 

Cullen and Dykman LLP

Legal Billing Clerk Job at Cullen and Dykman LLP

 ...Cullen and Dykman is seeking a full-time Legal Billing Clerk with legal billing knowledge for our high-volume insurance defense billing department to assist Billing Manager in reviewing bills for compliance with insurance guidelines. This position is in our Uniondale,... 

Dredge America Inc

Safety Manager Job at Dredge America Inc

 ...Summary: The Safety Manager position includes ensuring that all Dredge America project sites are operating safely and that a safety-first...  ...role. Manage and enforce safety programs that company with OSHA, MSHA, and other applicable safety regulations and standards.... 

Mission Recruiting

Attorney | Private Equity | 146925 Job at Mission Recruiting

 ...We are seeking a highly qualified attorney to join our team with a focus on private equity and M&A matters . The ideal candidate will have significant experience in drafting and negotiating key transaction documents, including purchase and merger agreements, LLC and... 

NJ Department of Environmental Protection

Environmental Educator (Hourly) Job at NJ Department of Environmental Protection

 ...qualifications) Opening Date: 5/8/2025 Closing Date: 5/29/2025 Existing Vacancies: 1 or more Program/Location Department of Environmental Protection State Parks, Forests & Historic Sites Office of Natural Lands Management 501 East State Street Trenton, NJ...