QA Manager

Organization
Aldevron
Job Location
Fargo
Fargo, ND 58104
Benefits

Health, Vision, Dental, Life, Long and Short Term Disability, 401k w/match, FSA/HSA, PTO

Job Description

Quality Assurance Manager

Position Summary:

The Quality Assurance Manager (QAM) is responsible for managing the quality system processes including, but not limited to: Internal Audits, CAPAs, Document Control and Supplier Quality.

Essential Duties and Responsibilities:

  • Responsible for maintaining quality assurance standards, processes and controls. Develops and implements methods for training.
  • Lead and assist with implementation and training of all employees regarding the quality system and GMP regulations.
  • Identifies and prioritizes compliance risks at Aldevron and provides oversight to ensure appropriate actions are taken to remediate these gaps or areas for improvement which includes:
    • Working collaboratively with cross functional departments
    • Works directly with operating entities to ensure that audits are conducted on a continuing basis as specified to enforce requirements and meet specifications
    • Lead or active member on project teams to ensure processes are performed in accordance with Aldevron procedures and all other business and regulatory requirements are met
    • Ensure gap assessments are performed as needed to applicable regulations and standards
  • Oversight and support of Lot Review/Release activities by ensuring:
    • Performance of review of batch and analytical data for accuracy and compliance with procedures for raw material, in-process and product release
    • Oversight of room/equipment release for usage
    • Support the Environmental Monitoring program
    • Review and approve QC product testing documentation and Certificate of Analysis supporting batch release
    • Issuance of Certificates of Analysis to clients
  •  Oversight and support of the CAPA system by:
    • Ensuring all events are adequately investigated
    • Appropriate CAPA actions are put into place
    • Records are closed within a timely manner
  • Support of Management Review by:
    • Generation of quality metrics associated with quality systems and compilation of all quarterly management review data submitted by all reporting parties.
    • Scheduling of quarterly management review meetings, ensuring attendance is captured and management approval of report and minutes obtained
    • Responsible for the scheduling and distribution of Management Review Reporting system
  • Assist oversight and support of Aldevron's internal audit program are performed in accordance with procedures and other applicable external requirements.  Appropriately and adequately identifying and prioritizing internal risks through the internal audit process and ensure deficiencies are addressed which includes:
    • Ensuring the generation of the annual internal audit schedule and obtaining approval
    • Overseeing or performance of internal audits as scheduled, maintaining documentation as required
    • Determining the need for focused audits based on identified compliance risk and ensuring performed
    • Ensuring auditors are qualified, independent, trained and assigned to audits as required
  • Oversight and support of Lot Review/Release activities by ensuring:
    • Performance of review of batch and analytical data for accuracy and compliance with procedures for raw material, in-process and product release
    • Oversight of room/equipment release for usage
    • Support the Environmental Monitoring program
    • Review and approve QC product testing documentation and Certificate of Analysis supporting batch release
    • Issuance of Certificates of Analysis to clients
  • Assist and support of the qualification and monitoring of Aldevron's suppliers/vendors which includes:
    • Ensuring the generation of the annual supplier quality audit schedule and obtaining approval
    • Overseeing or performance of supplier quality audits as scheduled, maintaining documentation as required
    • Ensuring auditors are qualified, independent, trained and assigned to audits as required
    • Maintenance of current supplier classifications, making available to the organization to support purchasing
  • Responsible for providing support during external inspections performed of Aldevron by regulatory agencies /clients and leading corrective actions resulting from inspection findings:
    • Assist in inspection readiness activities including, but not limited to:
      • Audit preparation activity
      • Subject matter expert identification & preparation
      • Scheduling and ensuring performance of facility walk through inspections
      • Ensuring adequate resources (conference rooms, general logistics, equipment, personnel etc.) are available to support/host
      • Ensuring required mitigation actions are performed during the inspection
    • Assist in ensuring inspection responses and follow-up activities are performed as required which may include:
      • Ensuring CAPAs are initiated for each finding as applicable
      • Ensuring that audit findings are appropriately addressed through corrective and preventive actions within agreed upon timeframes
      • Ensuring all inspection follow-up activity is coordinated/performed
  • Oversight and support of maintaining the Document Control process by ensuring all quality records within the Document Control system are maintained effectively, which includes:
    • Ensuring the completion of document periodic review schedule within required timeframe
    • Overseeing or performance of document updates as scheduled, maintaining documentation as required
  • Support of Aldevron's overall training program by:
    • Oversight and ensuring completion of annual regulatory training requirements
    • Develop and sustaining of a competency training program to meet regulatory expectations in demonstrating an individual is qualified to perform assigned tasks
    • Management of an electronic training system that supports all departments under Aldevron's quality system.
  • Support Change Control process by:
    • Review of change control requests to confirm required
    • Scheduling of change control meetings with the appropriate representatives based on the requested change.
    • Tracking of approved change control requests to ensure closed in a timely manner
  • All employees are responsible for the general upkeep of work and shared spaces.
  • Other duties as assigned.

Qualifications:

Experience:

  • At least 6 years of Quality Assurance or Regulatory Compliance experience in GxP environment.
  • Experience managing teams and complex projects
  • Must have personal experience with the FDA's GMP and GLP Guidelines as well as ISO experience. Ideally, candidate will have knowledge of FDA's phase I guidelines and GMPs related to production of molecular diagnostic controls.

Education:

  • Bachelor's degree in science

Skills and Knowledge:

  • Analytical skills and ability to apply statistics and metrics to process improvement models
  • Excellent oral and technical writing skills with the ability to interface effectively and professionally at all levels
  • Demonstrated leadership and organization skills

Abilities:

  • Ability to work on cross functional teams and apply influencing skills in a matrix environment
  • Must be able to develop solutions for simple and complex problems, which require a high degree of ingenuity, creativity and innovation. Challenges are frequently unique and solutions may serve as precedent for future decisions, which effect the entire organization.
  • Must be able to interpret, execute, and recommend modifications to company-wide policies to achieve corporate goals and objectives.

Personal characteristics:

  • Demonstrate high ethical standards, trustworthiness with strong communication and leadership skills.

Working Conditions:

This job operates in a professional office environment. This role routinely uses standard office equipment such as computers, phones, photocopiers/filing cabinets and fax machines.

Physical Requirements

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.

While performing the duties of this job, the employee is regularly required to see, talk and hear. The employee frequently is required to stand; walk; bend; lift up to 40 pounds; use arms, hands and fingers for various activities.  This position may stand or remain sedentary for long periods of time. 

Aldevron is a custom manufacturing organization that provides plasmid, protein and antibody development and production services. Headquartered in Fargo, ND with locations in Madison, WI and Freiburg, Germany we constantly look to innovate and advance life science through collaborative partnerships. Aldevron works with leaders in pharmaceutical, biotech and research institutions around the world to accelerate the development of drug, treatment and preventions for numerous diseases and genetic disorders. Our reputation for innovative solutions for our clients has allowed us to expand our organization and offerings in all service platforms. We are working in a landmark moment in the history of life science.

 EOE



For more information, or to apply now, you must go to the website below. Please DO NOT email your resume to us as we only accept applications through our website.

https://www.applicantpro.com/j/582562-149639 

How to Apply

For more information, or to apply now, you must go to the website below. Please DO NOT email your resume to us as we only accept applications through our website.

https://www.applicantpro.com/j/582562-149639 

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