QA Associate

3 weeks ago

Windsor, Canada ANI Pharmaceuticals, Inc. Full time
About Us
Welcome to ANI Pharmaceuticals, where we are dedicated to improving and enhancing patients' lives through the manufacturing and distribution of high-quality pharmaceutical products.
With a diverse portfolio of generic and branded pharmaceuticals, ANI is a trusted partner for healthcare providers, pharmacists, and patients alike. We understand the importance of accessibility, and our products are available across a wide range of therapeutic areas, contributing to the well-being of communities globally.

At ANI Pharmaceuticals, there are opportunities to contribute to our purpose every day. We value authenticity, knowledge, and hard work, we strive to celebrate our employees in a positive environment. Our culture empowers everyone to be successful and apply our full potential.

About the Role
This is an opportunity to join the QA team at the East Windsor, NJ facility. The position is Monday through Friday from 7:00 a.m. to 4:00 p.m. for the first shift or 4:00 p.m. to 12:00 a.m. for the second shift. This role will follow and ensure compliance with current GMP requirements and ANI SOPs.

Responsibilities
  • Perform room and equipment clearances following internal procedures after cleaning is performed by production.
  • Perform in-process checks while manufacturing and packaging of intermediate and finished product batches.
  • Collect in-process and finished product samples during manufacturing and packaging as per the batch record and protocol.
  • Review batch records online to ensure batch entries are made correctly.
  • Review materials are weighed correctly before initiation of the manufacturing.
  • Monitor production manufacturing areas for compliance with SOP, cGMP, and safety requirements.
  • Ensure batches are manufactured and packaged as per the batch record instructions.
  • Follow and comply with SOP and batch record requirements.
  • Identify and resolve routine errors during manufacturing and packaging to prevent possible deviations affecting production in real-time.
  • Ensure validation batches are manufactured as per the protocol requirements.
Skills
  • Understand the quality and safety requirements per the FDA regulations and SOPs.
  • Follow all defined SOPs.
  • Communicate work-related issues and details effectively with the supervisor and team members.
Requirements:
  • Hold a degree in science or life sciences.
  • 3-5 years of experience working in the pharmaceutical or related industry.
  • Knowledgeable around all FDA regulations and the ability to adhere to SOPs.
#J-18808-Ljbffr

  • QA Associate

    3 weeks ago

    Windsor, ON, Canada ANI Pharmaceuticals, Inc. Full time

    About Us Welcome to ANI Pharmaceuticals, where we are dedicated to improving and enhancing patients' lives through the manufacturing and distribution of high-quality pharmaceutical products. With a diverse portfolio of generic and branded pharmaceuticals, ANI is a trusted partner for healthcare providers, pharmacists, and patients alike. We understand...

  • Quality Assurance Associate

    4 weeks ago

    Windsor, Canada Catalent Full time

    **0080374 Quality Assurance Associate** **Position Summary** Catalent is a global, high-growth, public company, and a leading partner for the pharmaceutical industry in the development and manufacturing of new treatments for patients worldwide. Your talents, ideas, and passion are essential to our mission: to help people live better, healthier lives....

  • Regulatory Affairs Associate

    2 weeks ago

    Windsor, Canada Jamieson Wellness Inc. Full time

    Overall Responsibilities Reporting to the Supervisor, lnternational Regulatory Affairs the lnternational Regulatory Affairs Associate will prepare and maintain regulatory submissions to various international government regulatory bodies. The position requires regular interaction with the international sales and marketing department, all S&T areas, as well as...

  • Regulatory Affairs Associate

    5 days ago

    Windsor, Canada Jamieson Wellness Inc. Full time

    Overall ResponsibilitiesReporting to the Supervisor, lnternational Regulatory Affairs the lnternational Regulatory Affairs Associate will prepare and maintain regulatory submissions to various international government regulatory bodies. The position requires regular interaction with the international sales and marketing department, all S&T areas, as well as...

  • Regulatory Affairs Associate

    2 weeks ago

    Windsor, Canada Jamieson Wellness Inc. Full time

    Overall ResponsibilitiesReporting to the Supervisor, lnternational Regulatory Affairs the lnternational Regulatory Affairs Associate will prepare and maintain regulatory submissions to various international government regulatory bodies. The position requires regular interaction with the international sales and marketing department, all S&T areas, as well as...

  • Regulatory Affairs Associate

    3 days ago

    Windsor, Canada Jamieson Wellness Inc. Full time

    Overall ResponsibilitiesReporting to the Supervisor, lnternational Regulatory Affairs the lnternational Regulatory Affairs Associate will prepare and maintain regulatory submissions to various international government regulatory bodies. The position requires regular interaction with the international sales and marketing department, all S&T areas, as well as...

  • Regulatory Affairs Associate

    2 weeks ago

    Windsor, Canada Jamieson Wellness Inc. Full time

    Overall ResponsibilitiesReporting to the Supervisor, lnternational Regulatory Affairs the lnternational Regulatory Affairs Associate will prepare and maintain regulatory submissions to various international government regulatory bodies. The position requires regular interaction with the international sales and marketing department, all S&T areas, as well as...

  • Quality Assurance Senior Associate

    2 weeks ago

    Windsor, ON, Canada PEI BioAlliance Full time

    BIOVECTRA Inc. is a leading bio-science business in Prince Edward Island and Nova Scotia, focused on contract manufacturing and product development of active pharmaceutical ingredients, pharmaceutical intermediates, and bioreagents. BIOVECTRA has an opening for Senior Quality Assurance Associate. This is a permanent, full-time position than can be...

  • Regulatory Affairs Associate

    5 days ago

    Windsor, Ontario, Essex region, Canada Jamieson Wellness Inc. Full time

    Overall ResponsibilitiesReporting to the Supervisor, lnternational Regulatory Affairs the lnternational Regulatory Affairs Associate will prepare and maintain regulatory submissions to various international government regulatory bodies. The position requires regular interaction with the international sales and marketing department, all S&T areas, as well as...

  • Quality Assurance Specialist

    4 weeks ago

    Windsor, Canada Nexe Innovations Inc. Full time

    **Quality Assurance Specialist** NEXE INNOVATIONS INC. develops materials and technology for compostable single-serve packaging to confront the global problem of plastic pollution. We are seeking a qualified **Quality Assurance Manager **to join our team who can deliver effectively and on-time on the objectives of NEXE’s production and operation-related...

  • Medical Office Staff Associate

    3 weeks ago

    Windsor, ON, Canada ANI Pharmaceuticals, Inc. Full time

    Welcome to ANI Pharmaceuticals, where we are dedicated to improving and enhancing patients' lives through the manufacturing and distribution of high-quality pharmaceutical products. With a diverse portfolio of generic and branded pharmaceuticals, ANI is a trusted partner for healthcare providers, pharmacists, and patients alike. We understand the...

  • R&D Project Manager

    4 weeks ago

    Windsor, Canada ANI Pharmaceuticals, Inc. Full time

    About UsWelcome to ANI Pharmaceuticals, where we are dedicated to improving and enhancing patients' lives through the manufacturing and distribution of high-quality pharmaceutical products.With a diverse portfolio of generic and branded pharmaceuticals, ANI is a trusted partner for healthcare providers, pharmacists, and patients alike. We understand the...

  • R&D Project Manager

    3 weeks ago

    Windsor, Canada ANI Pharmaceuticals, Inc. Full time

    About UsWelcome to ANI Pharmaceuticals, where we are dedicated to improving and enhancing patients' lives through the manufacturing and distribution of high-quality pharmaceutical products.With a diverse portfolio of generic and branded pharmaceuticals, ANI is a trusted partner for healthcare providers, pharmacists, and patients alike. We understand the...

  • R&D Project Manager

    3 weeks ago

    Windsor, Canada ANI Pharmaceuticals, Inc. Full time

    About UsWelcome to ANI Pharmaceuticals, where we are dedicated to improving and enhancing patients' lives through the manufacturing and distribution of high-quality pharmaceutical products.With a diverse portfolio of generic and branded pharmaceuticals, ANI is a trusted partner for healthcare providers, pharmacists, and patients alike. We understand the...

  • R&D Project Manager

    3 weeks ago

    Windsor, ON, Canada ANI Pharmaceuticals, Inc. Full time

    About Us Welcome to ANI Pharmaceuticals, where we are dedicated to improving and enhancing patients' lives through the manufacturing and distribution of high-quality pharmaceutical products. With a diverse portfolio of generic and branded pharmaceuticals, ANI is a trusted partner for healthcare providers, pharmacists, and patients alike. We understand...