Quality Associate III

  • location: Research Triangle Park, NC
  • type: Contract
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job description

Quality Associate III

job summary:
We have a one year renewable position for a Quality Associate III with a client of ours in RTP, NC.





Obtain, analyze and interpret supply chain relevant data. Use analysis results to improve supply chain processes, performance and to reduce costs. Perform analyses with this data using analytical models and mathematical analysis. Typically holds a Bachelor's Degree and 5+ years of experience.















Additional Job Requirements













Posting Title: Associate III, Quality Assurance (Quality Engineering) Job Description: The Associate III responsibilities include, but are not limited to: Review of GMP raw data for compliance, review of GMP documentation, review of validation protocols (equipment, cleaning, and automation), review/approval of GMP procedures, identify gaps in existing Quality systems and propose solutions to site management. Assist in the development and implementation of Global Quality Systems, leading/supporting site and global initiatives, provides oversight with respect to the proper administration and adherence to all Biogen policies and procedures; adherence to all regulatory licenses and regulations, interfacing with key Quality, Manufacturing, and Engineering customers, and coordination of investigations impacting the RTP site; performs review of GMP documents and raw data for compliance to applicable procedures as well as regulatory and corporate guidance documents. The Associate III QE may support internal and external inspections, assess and approve discrepancies from site, corporate, and regulatory guidance. The QE Associate III will also support the Manager for activities related to interviewing, hiring and training of employees, as well as compliance with training policies. The Associate III of Quality Engineering will ensure that Quality systems within the Quality Assurance department remain in compliance with Biogen and industry cGMP standards. Additionally, the Associate III will ensure oversight and completion of all departmental milestones associated with clinical and commercial product manufacture. Failure to achieve results or erroneous decisions/recommendations may result in compliance issues, cause significant delays in schedules, cause financial repercussions, and/or may result in the re-allocation of additional, unplanned resources. Principal Accountabilities: - Facility, Utility, Equipment and Automation Validation review/approval of procedures, protocol/report approval. - Review/approval of change control documents and activities associated with change control implementation - Facility and equipment controls and release during shutdown, construction, product changeover. - Provide cGMP guidance and quality support of Manufacturing on the floor issues with equipment or systems, including assistance with deviation initiation. - Provide quality insight into Manufacturing Automations Systems lifecycle including: lifecycle process and documentation, computer systems validation, data integrity and system integration - Oversight of site changeover program including: review of Changeover documentation, Carry-Over calculations, Summary Reports and equipment release. - Review of PM workorders and CM work orders as applicable to cGMP systems - Proactive identification and resolution of both technical and compliance issues/gaps - Develops and implements aspects of various Quality Systems/System Improvements. - Performs QA review of alarm assessments for cGMP equipment - Supports internal and external inspections Qualifications: Requirements: - Demonstrated leadership capabilities. - Strong oral and written communication skills; ability to communicate with management, peers and subordinates effectively. - Strong organizational skills; ability to multi-task and coordinate multiple activities in parallel - Demonstrated problem solving skills - Demonstrated troubleshooting and problem-solving skills. - Knowledge of FDA/EMEA regulations and compliance. Work Experience: 3+ years of Quality-related experience in the following disciplines: - GMP review of validation documentation and strong knowledge of equipment/facilities/utility/automation systems - Knowledge of FDA/EMEA regulations and compliance. - Robust knowledge of current global Regulatory Quality requirements - Regulatory Agency inspection experience - Previous experience with Quality Systems oversight and development Education:





 
location: Durham, North Carolina
job type: Contract
work hours: 9am to 6pm
education: Bachelors
 
responsibilities:
We have a one year renewable position for a Quality Associate III with a client of ours in RTP, NC.





Obtain, analyze and interpret supply chain relevant data. Use analysis results to improve supply chain processes, performance and to reduce costs. Perform analyses with this data using analytical models and mathematical analysis. Typically holds a Bachelor's Degree and 5+ years of experience.















Additional Job Requirements













Posting Title: Associate III, Quality Assurance (Quality Engineering) Job Description: The Associate III responsibilities include, but are not limited to: Review of GMP raw data for compliance, review of GMP documentation, review of validation protocols (equipment, cleaning, and automation), review/approval of GMP procedures, identify gaps in existing Quality systems and propose solutions to site management. Assist in the development and implementation of Global Quality Systems, leading/supporting site and global initiatives, provides oversight with respect to the proper administration and adherence to all Biogen policies and procedures; adherence to all regulatory licenses and regulations, interfacing with key Quality, Manufacturing, and Engineering customers, and coordination of investigations impacting the RTP site; performs review of GMP documents and raw data for compliance to applicable procedures as well as regulatory and corporate guidance documents. The Associate III QE may support internal and external inspections, assess and approve discrepancies from site, corporate, and regulatory guidance. The QE Associate III will also support the Manager for activities related to interviewing, hiring and training of employees, as well as compliance with training policies. The Associate III of Quality Engineering will ensure that Quality systems within the Quality Assurance department remain in compliance with Biogen and industry cGMP standards. Additionally, the Associate III will ensure oversight and completion of all departmental milestones associated with clinical and commercial product manufacture. Failure to achieve results or erroneous decisions/recommendations may result in compliance issues, cause significant delays in schedules, cause financial repercussions, and/or may result in the re-allocation of additional, unplanned resources. Principal Accountabilities: - Facility, Utility, Equipment and Automation Validation review/approval of procedures, protocol/report approval. - Review/approval of change control documents and activities associated with change control implementation - Facility and equipment controls and release during shutdown, construction, product changeover. - Provide cGMP guidance and quality support of Manufacturing on the floor issues with equipment or systems, including assistance with deviation initiation. - Provide quality insight into Manufacturing Automations Systems lifecycle including: lifecycle process and documentation, computer systems validation, data integrity and system integration - Oversight of site changeover program including: review of Changeover documentation, Carry-Over calculations, Summary Reports and equipment release. - Review of PM workorders and CM work orders as applicable to cGMP systems - Proactive identification and resolution of both technical and compliance issues/gaps - Develops and implements aspects of various Quality Systems/System Improvements. - Performs QA review of alarm assessments for cGMP equipment - Supports internal and external inspections Qualifications: Requirements: - Demonstrated leadership capabilities. - Strong oral and written communication skills; ability to communicate with management, peers and subordinates effectively. - Strong organizational skills; ability to multi-task and coordinate multiple activities in parallel - Demonstrated problem solving skills - Demonstrated troubleshooting and problem-solving skills. - Knowledge of FDA/EMEA regulations and compliance. Work Experience: 3+ years of Quality-related experience in the following disciplines: - GMP review of validation documentation and strong knowledge of equipment/facilities/utility/automation systems - Knowledge of FDA/EMEA regulations and compliance. - Robust knowledge of current global Regulatory Quality requirements - Regulatory Agency inspection experience - Previous experience with Quality Systems oversight and development Education:





 
qualifications:
We have a one year renewable position for a Quality Associate III with a client of ours in RTP, NC.





Obtain, analyze and interpret supply chain relevant data. Use analysis results to improve supply chain processes, performance and to reduce costs. Perform analyses with this data using analytical models and mathematical analysis. Typically holds a Bachelor's Degree and 5+ years of experience.















Additional Job Requirements













Posting Title: Associate III, Quality Assurance (Quality Engineering) Job Description: The Associate III responsibilities include, but are not limited to: Review of GMP raw data for compliance, review of GMP documentation, review of validation protocols (equipment, cleaning, and automation), review/approval of GMP procedures, identify gaps in existing Quality systems and propose solutions to site management. Assist in the development and implementation of Global Quality Systems, leading/supporting site and global initiatives, provides oversight with respect to the proper administration and adherence to all Biogen policies and procedures; adherence to all regulatory licenses and regulations, interfacing with key Quality, Manufacturing, and Engineering customers, and coordination of investigations impacting the RTP site; performs review of GMP documents and raw data for compliance to applicable procedures as well as regulatory and corporate guidance documents. The Associate III QE may support internal and external inspections, assess and approve discrepancies from site, corporate, and regulatory guidance. The QE Associate III will also support the Manager for activities related to interviewing, hiring and training of employees, as well as compliance with training policies. The Associate III of Quality Engineering will ensure that Quality systems within the Quality Assurance department remain in compliance with Biogen and industry cGMP standards. Additionally, the Associate III will ensure oversight and completion of all departmental milestones associated with clinical and commercial product manufacture. Failure to achieve results or erroneous decisions/recommendations may result in compliance issues, cause significant delays in schedules, cause financial repercussions, and/or may result in the re-allocation of additional, unplanned resources. Principal Accountabilities: - Facility, Utility, Equipment and Automation Validation review/approval of procedures, protocol/report approval. - Review/approval of change control documents and activities associated with change control implementation - Facility and equipment controls and release during shutdown, construction, product changeover. - Provide cGMP guidance and quality support of Manufacturing on the floor issues with equipment or systems, including assistance with deviation initiation. - Provide quality insight into Manufacturing Automations Systems lifecycle including: lifecycle process and documentation, computer systems validation, data integrity and system integration - Oversight of site changeover program including: review of Changeover documentation, Carry-Over calculations, Summary Reports and equipment release. - Review of PM workorders and CM work orders as applicable to cGMP systems - Proactive identification and resolution of both technical and compliance issues/gaps - Develops and implements aspects of various Quality Systems/System Improvements. - Performs QA review of alarm assessments for cGMP equipment - Supports internal and external inspections Qualifications: Requirements: - Demonstrated leadership capabilities. - Strong oral and written communication skills; ability to communicate with management, peers and subordinates effectively. - Strong organizational skills; ability to multi-task and coordinate multiple activities in parallel - Demonstrated problem solving skills - Demonstrated troubleshooting and problem-solving skills. - Knowledge of FDA/EMEA regulations and compliance. Work Experience: 3+ years of Quality-related experience in the following disciplines: - GMP review of validation documentation and strong knowledge of equipment/facilities/utility/automation systems - Knowledge of FDA/EMEA regulations and compliance. - Robust knowledge of current global Regulatory Quality requirements - Regulatory Agency inspection experience - Previous experience with Quality Systems oversight and development Education:





 
skills: We have a one year renewable position for a Quality Associate III with a client of ours in RTP, NC.





Obtain, analyze and interpret supply chain relevant data. Use analysis results to improve supply chain processes, performance and to reduce costs. Perform analyses with this data using analytical models and mathematical analysis. Typically holds a Bachelor's Degree and 5+ years of experience.















Additional Job Requirements













Posting Title: Associate III, Quality Assurance (Quality Engineering) Job Description: The Associate III responsibilities include, but are not limited to: Review of GMP raw data for compliance, review of GMP documentation, review of validation protocols (equipment, cleaning, and automation), review/approval of GMP procedures, identify gaps in existing Quality systems and propose solutions to site management. Assist in the development and implementation of Global Quality Systems, leading/supporting site and global initiatives, provides oversight with respect to the proper administration and adherence to all Biogen policies and procedures; adherence to all regulatory licenses and regulations, interfacing with key Quality, Manufacturing, and Engineering customers, and coordination of investigations impacting the RTP site; performs review of GMP documents and raw data for compliance to applicable procedures as well as regulatory and corporate guidance documents. The Associate III QE may support internal and external inspections, assess and approve discrepancies from site, corporate, and regulatory guidance. The QE Associate III will also support the Manager for activities related to interviewing, hiring and training of employees, as well as compliance with training policies. The Associate III of Quality Engineering will ensure that Quality systems within the Quality Assurance department remain in compliance with Biogen and industry cGMP standards. Additionally, the Associate III will ensure oversight and completion of all departmental milestones associated with clinical and commercial product manufacture. Failure to achieve results or erroneous decisions/recommendations may result in compliance issues, cause significant delays in schedules, cause financial repercussions, and/or may result in the re-allocation of additional, unplanned resources. Principal Accountabilities: - Facility, Utility, Equipment and Automation Validation review/approval of procedures, protocol/report approval. - Review/approval of change control documents and activities associated with change control implementation - Facility and equipment controls and release during shutdown, construction, product changeover. - Provide cGMP guidance and quality support of Manufacturing on the floor issues with equipment or systems, including assistance with deviation initiation. - Provide quality insight into Manufacturing Automations Systems lifecycle including: lifecycle process and documentation, computer systems validation, data integrity and system integration - Oversight of site changeover program including: review of Changeover documentation, Carry-Over calculations, Summary Reports and equipment release. - Review of PM workorders and CM work orders as applicable to cGMP systems - Proactive identification and resolution of both technical and compliance issues/gaps - Develops and implements aspects of various Quality Systems/System Improvements. - Performs QA review of alarm assessments for cGMP equipment - Supports internal and external inspections Qualifications: Requirements: - Demonstrated leadership capabilities. - Strong oral and written communication skills; ability to communicate with management, peers and subordinates effectively. - Strong organizational skills; ability to multi-task and coordinate multiple activities in parallel - Demonstrated problem solving skills - Demonstrated troubleshooting and problem-solving skills. - Knowledge of FDA/EMEA regulations and compliance. Work Experience: 3+ years of Quality-related experience in the following disciplines: - GMP review of validation documentation and strong knowledge of equipment/facilities/utility/automation systems - Knowledge of FDA/EMEA regulations and compliance. - Robust knowledge of current global Regulatory Quality requirements - Regulatory Agency inspection experience - Previous experience with Quality Systems oversight and development Education:






Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.

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