QC Shift Manager

3 weeks ago

Union County, United States AstrixTechnology LLC Full time $105,000 - $110,000
Job DescriptionJob Description

Our client, a leading contract development and manufacturing organization (CDMO) based in the US, is seeking a QC Chemist Manager to join their growing team. This is a great opportunity to contribute to the development and commercialization efforts.

Pay: 105k-110k/year
Location: Union County, NJ
Shifts: Sun-Wed (9pm-8am), Sun- Wed (7am-6pm)

Responsibilities:

  • Oversee and conduct QC testing, while preparing and maintaining stability records and summaries.
  • Develop, train, and transfer methods to and from QC and contract manufacturers as needed.
  • Modify and validate analytical procedures to meet QC requirements.
  • Design and develop experimental protocols, SOPs, and related documentation in line with cGMP/GLP standards.
  • Perform all QC chemical tests required for batch release to ensure patient safety.
  • Participate in and lead special projects, providing input, feedback, and executing assigned tasks.
  • Tackle special projects focused on analytical and instrumentation problem-solving.
  • Perform timely microbiological QC, ensuring product quality records are accurate.
  • Maintain, operate, and adapt analytical instrumentation as needed.
  • Ensure a clean, safe work environment that complies with safety and pharmaceutical regulations.
  • Conduct  safety tasks in accordance with regulatory standards.
  • Report monthly on QC supply orders for devices and reagents.
  • Contribute to industrial, R&D qualification, and validation activities, while supporting routine maintenance.
  • Lead laboratory investigations and root-cause analyses.
  • Prepare chemical reagents for manufacturing and QC processes.

Qualifications:

  • A minimum of 5 years of GMP QC laboratory experience, including leadership experience.
  • Strong organizational skills are essential.
  • Bachelor’s degree in chemistry or Biochemistry is required.
  • Proficiency with analytical techniques, including High-Performance Liquid Chromatography (HPLC) 
  • Excellent oral and written communication, organizational, and problem-solving skills, with the ability to work under strict timelines.
  • Ability to simplify complex ideas for management and customers, and exercise independent judgment during method development and transfer processes.
  • Knowledge of current analytical methods for testing, release, and stability of sterile pharmaceutical products.
  • A team-oriented mindset, with the ability to work effectively with cross-functional teams.
  • Proficiency in Microsoft Word and experience with Laboratory Information Management Systems (LIMS).
Company DescriptionSince 1995 Astrix has been delivering information technology consulting, regulatory advisory services and staffing solutions to the scientific community. We can assist in augmenting your internal resources to deliver optimum solutions on time and within budget. It is our goal to simply do it right. We work everyday to create value and build trust with our clients, employees, partners and vendors.

Astrix provides scientists to a broad spectrum of scientific based industries including: Chemical, Biotech, Pharmaceutical, Cosmetics, Food Science, Flavors and Fragrances, Biomedical, Consumer Products, Environmental, Medical device, Petrochemical and Clinical Research.Company DescriptionSince 1995 Astrix has been delivering information technology consulting, regulatory advisory services and staffing solutions to the scientific community. We can assist in augmenting your internal resources to deliver optimum solutions on time and within budget. It is our goal to simply do it right. We work everyday to create value and build trust with our clients, employees, partners and vendors.\r
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Astrix provides scientists to a broad spectrum of scientific based industries including: Chemical, Biotech, Pharmaceutical, Cosmetics, Food Science, Flavors and Fragrances, Biomedical, Consumer Products, Environmental, Medical device, Petrochemical and Clinical Research.

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