Quality Assurance Manager

4 weeks ago

Deerfield Beach, Florida, United States Pherros Biosciences Full time

About the Role

Pherros Biosciences is seeking a Quality Assurance Manager to join our dedicated and highly effective quality assurance operations team. As a key member of our team, you will be responsible for evaluating and reviewing manufacturing activities, including technical transfers, complex investigations, change controls, and other activities as needed. You will also be involved in Quality Agreements as required. Your expertise will help identify deviations from established standards in the manufacture of products, and you will approve investigations and change control activities to ensure compliance with policies/GMPs. You will engage in batch review/disposition/release activities as required, and your problem-solving skills will make us ready to achieve new milestones and help patients across the globe.

Key Responsibilities

As a Quality Assurance Manager, you will execute batch release processes and provide oversight of product manufactured internally and externally. You will manage the department's workload, conduct performance planning, and coach employees. You will also ensure drug product manufacturing is carried out in a compliant manner in accordance with current Quality Standards, Quality Agreements, and current Good Manufacturing Practices (cGMPs). Additional specific responsibilities include:

  • Manager quality assurance personnel and ensure appropriate quality systems are in place and that the roles and responsibilities of the quality unit are carried for drug product manufacturing.
  • Provide direction for day-to-day activities and decisions associated with the manufacturing of drug product, escalating when appropriate.
  • Review and approve GMP documentation including complaints, deviations, investigations, changes, procedures, and training.
  • Ensure a self-inspection program is in place and participate in internal and external audits.
  • Influence cross-functional manufacturing groups to maintain and improve the quality system.
  • Foster an inclusive environment where continuous improvement and innovative ideas are implemented.
  • Provide guidance, participate in projects, manage own time to meet objectives, plan resource requirements for projects throughout the organization.
  • Drive continuous improvement activities.
  • Engage in continuous inspection readiness for Quality Assurance.
  • Drive effective management of quality issues and Corrective Action Plan (CAPAs) and make decisions that may involve complex quality and technical issues.
  • Ensure appropriate networking and sharing of best practices with corporate compliance colleagues and with other compliance functions.

Requirements

To be successful in this role, you will need to have a Bachelor's degree in a science-related field and at least 10 years of relevant experience, including supporting cGMP manufacturing. You will also need to have cGMP manufacturing/quality experience, including experience in the resolution of deviations or product defects, application of regulations as related to vendor management programs and other industry quality systems and processes. A proactive approach and strong critical thinking skills are essential, as well as strong collaboration, relationship management, and interpersonal skills. Excellent written and verbal communication skills are also required, as well as advanced computer skills in MS Office applications and experience operating within quality enterprise systems.

Preferred Qualifications

Familiarity with a Quality Management System, such as Master Control, is a plus, as is experience participating in internal Good Manufacturing Practices (cGMP) audits and support regulatory inspections or corporate audit activities. Experience communicating with and influencing internal and external customers across site and department boundaries to ensure compliant and aligned resolution of project-related issues and investigations is also desirable. Experience ensuring appropriate internal networking to develop and maintain close and effective business partner relationships with internal colleagues is also a plus.

About Us

Pherros Biosciences is a global biotechnology company dedicated to improving future healthcare and transforming millions of lives. We are committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability, or veteran status. We also comply with all applicable national, state, and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA.

  • Quality Assurance Specialist

    4 weeks ago

    Deerfield Beach, Florida, United States Covestro AG Full time

    Job SummaryWe are seeking a highly skilled Quality Assurance Specialist to support our manufacturing processes at the Covestro South Deerfield Site. The ideal candidate will have a strong background in quality management and a passion for ensuring the highest standards of quality in our products.The Quality Assurance Specialist will be responsible for...

  • Quality Assurance Specialist

    4 weeks ago

    Deerfield Beach, Florida, United States Covestro AG Full time

    Job SummaryWe are seeking a highly skilled Quality Assurance Specialist to support our manufacturing processes at the Covestro South Deerfield Site.The successful candidate will be responsible for developing and maintaining Quality systems used for the production of Thermoplastic Polyurethane and Polycarbonate films and sheets that meet internal Quality...

  • Quality Assurance Specialist

    3 weeks ago

    Deerfield Beach, Florida, United States BioStem Technologies Full time

    Job SummaryThe Quality Assurance Associate will be responsible for ensuring the quality and compliance of BioStem products. This role will support the timely release of incoming materials through final disposition.Key ResponsibilitiesEnsure adherence to Standard Operating Procedures (SOPs) and Good Documentation Practices.Verify labels throughout...

  • Manufacturing Medical Quality Assurance Specialist

    4 weeks ago

    Deerfield Beach, Florida, United States Global Channel Management Full time

    About the role: We are seeking a highly skilled Manufacturing Medical Quality Assurance Specialist to join our team at Global Channel Management. The ideal candidate will have a strong background in quality assurance and a passion for ensuring the highest standards of quality in medical device manufacturing.Key responsibilities:Conduct batch record reviews...

  • Senior Quality Assurance Specialist

    4 weeks ago

    Deerfield Beach, Florida, United States Path Engineering Full time

    Quality Assurance SpecialistAt Path Engineering, we're seeking a highly skilled Quality Assurance Specialist to join our team. As a key member of our quality team, you'll be responsible for leading failure investigations, conducting process stability and capability studies, and acting as the Lead Internal Auditor.Key Responsibilities:Lead failure...

  • Quality Assurance Manager

    4 weeks ago

    West Palm Beach, Florida, United States QISG Full time

    Job OverviewWe are seeking a highly skilled Quality Assurance Manager to join our team at QISG. The successful candidate will be responsible for ensuring the highest standards of quality in our projects, working closely with project managers and construction managers to monitor and audit quality management requirements.Key Responsibilities:Develop and...

  • Quality Assurance Manager

    4 weeks ago

    West Palm Beach, Florida, United States Lutheran Services Florida Full time

    Lutheran Services Florida (LSF) is seeking a talented Quality Assurance Manager to join our team. As a Quality Assurance Manager, you will be responsible for managing and providing oversight of the monitoring and tracking activities conducted within the Head Start/Early Head Start Programs to meet compliance mandates defined by the Head Start Performance...

  • Lead Internal Auditor, Quality Assurance Specialist

    3 weeks ago

    Deerfield Beach, Florida, United States Discover Full time

    Job Description:As a Lead Internal Auditor, Quality Assurance Specialist at Discover, you will play a critical role in ensuring the integrity and quality of our operations. Your primary responsibility will be to perform audit reviews, conducting client interviews, reviewing business processes, identifying and assessing controls, and communicating results...

  • Manufacturing Quality Assurance Specialist

    4 weeks ago

    Deerfield Beach, Florida, United States Global Channel Management Full time

    About the JobWe are seeking a highly skilled Manufacturing Medical Quality Analyst to join our team at Global Channel Management.Key ResponsibilitiesConduct batch record reviews at the final stage of the manufacturing process with minimal assistance and approve final release once compliance and procedural requirements are met.Identify batch record issues and...

  • Manufacturing Quality Assurance Specialist

    4 weeks ago

    Deerfield Beach, Florida, United States Global Channel Management Full time

    About the JobWe are seeking a highly skilled Manufacturing Medical Quality Analyst to join our team at Global Channel Management.Key ResponsibilitiesConduct batch record reviews at the final stage of the manufacturing process with minimal assistance and approve final release once compliance and procedural requirements are met.Identify batch record issues and...

  • Quality Assurance Production Manager

    3 weeks ago

    West Palm Beach, Florida, United States TooJay's Deli Full time

    Job Summary:TooJay's Deli is seeking a highly skilled Quality Assurance Production Manager to join our team. As a key member of our operations team, you will be responsible for ensuring the highest standards of food safety and quality in our master prep kitchen.Key Responsibilities:Develop, implement, and manage quality assurance programs, policies, and...

  • Quality Assurance Specialist

    3 weeks ago

    Deerfield Beach, Florida, United States ZOLL Medical Full time

    Job Summary: As a Quality Control Inspector at ZOLL Medical, you will play a critical role in ensuring the conformance of medical device products to specifications. Your responsibilities will include in-process and final inspection of products, verification of packaged materials and sub-assemblies, and maintenance of quality testing information.Key...

  • Quality Assurance Intern

    4 weeks ago

    Ormond Beach, Florida, United States ABB Full time

    We are seeking a highly motivated and detail-oriented Quality Assurance Intern to join our team at ABB. As a Quality Assurance Intern, you will have the opportunity to gain hands-on experience in manufacturing transformation activities, including layout improvements, tool organization, and visual management.You will work closely with the operations team to...

  • Quality Assurance Specialist

    3 weeks ago

    West Palm Beach, Florida, United States Alleima Full time

    Quality Assurance SpecialistAt Alleima, we are seeking a Quality Assurance Specialist to join our team. As a Quality Assurance Specialist, you will be responsible for developing and implementing documentation, procedures, and work instructions to support the quality management function.You will manage customer complaints, internal nonconformances, and...

  • Quality Assurance Director

    4 weeks ago

    Delray Beach, Florida, United States GCR Professional Services Full time

    Job Title: Quality Assurance ManagerCitizenship is a key aspect of this role.Job Duties:Lead the Quality and Inspection Team in developing and maintaining a system to ensure quality standards are met.Collaborate with team members to identify and implement process improvements.Develop and maintain quality control procedures to ensure compliance with...

  • Quality Assurance Specialist

    3 weeks ago

    Daytona Beach, Florida, United States B. Braun Medical Inc Full time

    Job Title: Quality Assurance SpecialistAbout the Role:We are seeking a highly skilled Quality Assurance Specialist to join our team at B. Braun Medical Inc. As a Quality Assurance Specialist, you will be responsible for developing and implementing processes and procedures to improve quality throughout the organization.Key Responsibilities:- Develop and...

  • Quality Assurance Specialist

    4 weeks ago

    Fort Walton Beach, Florida, United States Insight Global Full time

    Job Title: Quality Assurance SpecialistWe are seeking a highly skilled Quality Assurance Specialist to join our team at Insight Global. As a Quality Assurance Specialist, you will play a critical role in ensuring the exceptional quality of our products while maintaining stringent safety standards and upholding ISO 9001, AS9100, and other required quality...

  • Quality Assurance Specialist

    4 weeks ago

    Delray Beach, Florida, United States Plastimold Products Inc Full time

    Job DescriptionWe are seeking a detail-oriented Quality Assurance Specialist to ensure our products meet quality standards and regulatory requirements. The successful candidate will be responsible for utilizing our system to carry out inspections, read 2D drawings, and use measurement equipment such as calipers and micrometers.Responsibilities:Utilize our...

  • Quality Assurance Specialist

    4 weeks ago

    Fort Walton Beach, Florida, United States Insight Global Full time

    We are seeking a Quality Assurance Specialist to support our team at Insight Global. This individual will be responsible for inspecting electronic components daily to ensure they meet the highest quality standards.The Quality Assurance Specialist will work closely with our team to ensure the exceptional quality of our products while maintaining stringent...

  • Quality Assurance Specialist

    4 weeks ago

    Daytona Beach, Florida, United States B. Braun Medical Inc Full time

    About B. Braun Medical Inc.B. Braun Medical Inc. is a leading manufacturer of medical products and services, dedicated to improving patient care and safety. Our company is committed to innovation, quality, and customer satisfaction.Job SummaryWe are seeking a highly motivated and detail-oriented Quality Assurance Specialist to join our team. As a Quality...