MQA Quality Associate

1 month ago

Portage IN United States Actalent Full time

Description:

Responsibilities:

  • Monitors all operations pertaining to manufacturing to ensure adherence to AQST policies and procedures and provides guidance and clarity to colleagues to ensure consistent approaches to product quality are applied.
  • Conducts routine internal audits and facility walkthroughs to ensure compliance with internal quality system requirements and to maintain a state of audit readiness.
  • Initiates and investigates nonconformances, project managing to resolve quality issues by partnering with other functions.
  • Author and review Forms, Batch Records, WI, SOPs, Protocols in electronic document management system
  • Investigates assigned product quality complaints utilizing knowledge of the manufacturing and quality processes at Aquestive.
  • Owns CAPA records and action item implementation, partnering with operations, supply chain, engineering, and QC staff to ensure corrective actions are implemented according to approved timelines and ensuring their effectiveness post-implementation.
  • Coordinates the Environmental Monitoring program including scheduling of third-party water testing, sampling, and report generation.
  • Short to medium term (3-12 months) project owner for quality projects to improve efficiency or compliance profile.
  • Understands the manufacturing schedule and provides quality support to ensure business continuity and seamless transitions between manufacturing stages.
  • Operates with a sense of urgency in a fast-paced environment.
  • Performs real time review of operational records, including Batch Records, and assists in obtaining any required corrections.
  • Pulls the AQL samples during packaging of finished product based on sampling instructions.
  • Performs AQL testing by verifying appearance, weight, dimensions of pouch and strip, presence of print on strip and pouch, and seal integrity for each AQL sample pulled.
  • Records results from each AQL test performed.
  • Communicates AQL alert, action or failure limits to the Quality Assurance and Operation Supervisor.
  • Segregates impacted population criteria based on AQL testing results and communicating criteria for such to the Operations Supervisor and packaging operators.
  • Performs stability sampling, finished product sampling, micro and in process sampling and bringing samples to the lab, per the appropriate protocol or sampling instructions.
  • Demonstrates good understanding of AQL procedures and guidelines after applicable training.
  • Performs other duties as instructed by QA Supervisors.
  • Trains and performs batch record review during production operations, line clearance and control procedures, IPC testing, scale/balance verification and other assigned production support duties as deemed appropriate.

Skills & Qualifications:

  • Minimum 2-year college degree in the Sciences (biology or chemistry) or equivalent experience.
  • 2+ years in pharmaceutical or other regulated industry.
  • Ability to understand and follow Standard Operating Procedures.
  • Strong working knowledge of cGMPs.
  • Demonstrated knowledge of quality systems, GMPs, industry standards, and regulatory requirements for the manufacture, testing, and release of pharmaceutical products.
  • Formal training in Quality disciplines (auditing, engineering, process improvement) as demonstrated through certification (ASQ, Lean Six Sigma, etc.) highly preferred.
  • Technical proficiency at reviewing/auditing production records, reports and/or GMP related documentation.
  • Ability to work within a team environment and willingness to contribute to the overall goals of the company.
  • Ability to lead project teams.
  • The ability to handle multiple assignments and projects with competing priorities while independently managing time is critical.
  • Good organizational skills, high level of attention to detail, excellent oral and written communication skills with the ability to interact at all levels.
  • Owns a driver’s license and can travel between production facilities (

  • Advanced Quality Technician, Manufacturing Quality Assurance

    1 week ago

    Portage, United States Ursitti Enterprises LLC Full time

    Job DescriptionJob DescriptionLeading Pharmaceutical Manufacturer Requires an MQA Technician at their Portage Facility! If you meet the qualifications below, APPLY NOW! Job Summary Partners with operations to lead in developing, implementing, and maintaining quality systems that support manufacturing operations to meet product and process quality metrics....

  • Advanced Quality Technician, Manufacturing Quality Assurance

    2 days ago

    Portage, United States Ursitti Enterprises LLC Full time

    Job DescriptionJob DescriptionLeading Pharmaceutical Manufacturer Requires an MQA Technician at their Portage Facility! If you meet the qualifications below, APPLY NOW! Job Summary Partners with operations to lead in developing, implementing, and maintaining quality systems that support manufacturing operations to meet product and process quality metrics....

  • Quality Control Associate

    1 week ago

    Portage, United States Northern Biomedical Research Inc Full time

    Job DescriptionJob Description Role SummaryThe Quality Control Associate will provide quality support by means of thorough review of data collected and generated within the laboratory. Additionally, the Quality Control Associate will be responsible for compiling data from various source documents, completing data tabulation, reviewing raw data and results...

  • Senior Quality Associate

    2 weeks ago

    Portage, United States Aquestive Therapeutics Full time

    Job Summary: This position is responsible for ensuring compliance with pharmaceutical industry regulations and standards as well as company policies and procedures. This position is responsible for performing quality functions not limited to the manufacturing, review and approval of quality related documentation and ensuring compliance during manufacturing...

  • Senior Quality Associate

    1 week ago

    Portage, United States Aquestive Therapeutics Full time

    Job Summary: This position is responsible for ensuring compliance with pharmaceutical industry regulations and standards as well as company policies and procedures. This position is responsible for performing quality functions not limited to the manufacturing, review and approval of quality related documentation and ensuring compliance during manufacturing...

  • Senior Quality Associate

    1 week ago

    Portage, United States Aquestive Therapeutics Full time

    Job Summary: This position is responsible for ensuring compliance with pharmaceutical industry regulations and standards as well as company policies and procedures. This position is responsible for performing quality functions not limited to the manufacturing, review and approval of quality­ related documentation and ensuring compliance during manufacturing...

  • Senior Quality Associate

    2 days ago

    Portage, United States Aquestive Therapeutics Full time

    Job Summary: This position is responsible for ensuring compliance with pharmaceutical industry regulations and standards as well as company policies and procedures. This position is responsible for performing quality functions not limited to the manufacturing, review and approval of quality­ related documentation and ensuring compliance during manufacturing...

  • Manufacturing Quality Associate

    3 weeks ago

    Portage, United States Ursitti Enterprises LLC Full time

    Job DescriptionJob DescriptionLeading Pharmaceutical Manufacturer Requires Manufacturing Quality Associate Technicians at their Portage Facility! If you meet the qualifications below, APPLY NOW!Job Summary The Manufacturing Quality Associate is responsible for ensuring quality and compliance during the day-to-day operations in the manufacturing environment...

  • Manufacturing Quality Associate

    2 days ago

    Portage, United States Ursitti Enterprises LLC Full time

    Job DescriptionJob DescriptionLeading Pharmaceutical Manufacturer Requires Manufacturing Quality Associate Technicians at their Portage Facility! If you meet the qualifications below, APPLY NOW!Job Summary The Manufacturing Quality Associate is responsible for ensuring quality and compliance during the day-to-day operations in the manufacturing environment...

  • Quality Coordinator

    3 weeks ago

    Portage, United States MonoSol LLC Full time

    Job DetailsJob LocationPortage IN - Portage, INDescriptionPosition Summary: Lead the document control activities in support of the QMS Quality Management System and provide administrative support to the Quality System department.Primary Responsibilities:The coordinator is our Document Control champion and administrator in our Electronic Document Management...

  • Quality Coordinator

    7 days ago

    Portage, United States MonoSol LLC Full time

    Job DetailsJob Location Portage IN - Portage, IN DescriptionPosition Summary: Lead the document control activities in support of the QMS Quality Management System and provide administrative support to the Quality System department. Primary Responsibilities: The coordinator is our Document Control champion and administrator in our Electronic Document...

  • Quality Technician

    2 weeks ago

    Portage, United States Leeco Steel Full time

    Leeco Steel, North America's leading supplier of carbon, HSLA and alloy steel plate, is seeking a highly- motivated, detail-oriented quality technician for our Portage, IN facility.Job Summary:Assist the Quality Team in the tasks associated with maintaining the Quality management System and assuring customer specifications and requirements are...

  • Quality Technician

    2 days ago

    Portage, United States O'Neal Industries Inc. Full time

    Description Leeco Steel, North America’s leading supplier of carbon, HSLA and alloy steel plate, is seeking a highly- motivated, detail-oriented quality technician for our Portage, IN facility. Job Summary: Assist the Quality Team in the tasks associated with maintaining the Quality management System and assuring customer specifications and requirements...

  • Quality Technician

    2 weeks ago

    Portage, United States Leeco Steel Full time

    Leeco Steel, North America’s leading supplier of carbon, HSLA and alloy steel plate, is seeking a highly- motivated, detail-oriented quality technician for our Portage, IN facility. Job Summary: Assist the Quality Team in the tasks associated with maintaining the Quality management System and assuring customer specifications and requirements are met....

  • Quality Technician

    2 weeks ago

    Portage, United States Leeco Steel Full time

    Leeco Steel, North America's leading supplier of carbon, HSLA and alloy steel plate, is seeking a highly- motivated, detail-oriented quality technician for our Portage, IN facility. Job Summary:Assist the Quality Team in the tasks associated with maintaining the Quality management System and assuring customer specifications and requirements are met....

  • Quality Technician

    2 days ago

    Portage, United States Leeco Steel Full time

    Leeco Steel, North America’s leading supplier of carbon, HSLA and alloy steel plate, is seeking a highly- motivated, detail-oriented quality technician for our Portage, IN facility. Job Summary: Assist the Quality Team in the tasks associated with maintaining the Quality management System and assuring customer specifications and requirements are met....

  • Quality Technician

    2 weeks ago

    Portage, United States O'Neal Industries Inc. Full time

    Description Leeco Steel, North America's leading supplier of carbon, HSLA and alloy steel plate, is seeking a highly- motivated, detail-oriented quality technician for our Portage, IN facility. Job Summary: Assist the Quality Team in the tasks associated with maintaining the Quality management System and assuring customer specifications and requirements are...

  • Quality Technician

    2 weeks ago

    Portage, United States O'Neal Industries Inc. Full time

    Description Leeco Steel, North America’s leading supplier of carbon, HSLA and alloy steel plate, is seeking a highly- motivated, detail-oriented quality technician for our Portage, IN facility. Job Summary: Assist the Quality Team in the tasks associated with maintaining the Quality management System and assuring customer specifications and requirements...

  • Quality Systems Associate

    2 weeks ago

    IN-Griffith, United States GRIFOLS, S.A. Full time

    Would you like to join an international team working to improve the future of healthcare? Do you want to enhance the lives of millions of people? Grifols is a global healthcare company that since 1909 has been working to improve the health and well-being of people around the world. We are leaders in plasma-derived medicines and transfusion medicine and...

  • Quality Systems Associate

    2 days ago

    IN-Griffith, United States GRIFOLS, S.A. Full time

    Would you like to join an international team working to improve the future of healthcare? Do you want to enhance the lives of millions of people? Grifols is a global healthcare company that since 1909 has been working to improve the health and well-being of people around the world. We are leaders in plasma-derived medicines and transfusion medicine and...