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QA Senior Consultant - Riverview, MI


Azzur Group

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Not provided by employer

·       $69.6K to $88.2K per year is Indeed's estimated salary for senior consultant at Azzur Consulting in Riverview, MI.

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POSITION SUMMARY:

The Senior Quality Assurance (QA) Associate will directly support the implementation, execution, and maintenance of Quality Systems to ensure compliance with regulatory requirements as propagated by the United States Food and Drug Administration (USFDA) and other international regulatory authorities. Principle assignments related to compliance may include material release, review, and implementation of new and revised documentation to support Quality Systems and operations, internal and external audits, and training of personnel to meet Good Manufacturing Process (GMP) requirements. The scope of this position will support both clinical and commercial manufacturing as well as process development.


Skill and/or ability required:

Shall adhere to all applicable regulatory requirements, including FDA, EPA, OSHA, and related safety, health and environmental procedures, policies and practices.
• Consistent support and practice of all mission, vision, and values.
• Identify and protect the original technical information as part of the company property.


KEY RESPONSIBILITIES:

Review of batch production records (including analytical test packages, cleaning records, etc.: The incumbent’s primary responsibility will be to ensure that batches meet GMP requirements and are manufactured according to approved Standard Operating Procedures (SOP), finished products meet specifications before releasing it to the client, and appropriate resolution to batches pending approval due to GMP errors and related corrective action investigations. Review in-process batch records finished product batch records and intermediate analytical records. Release raw materials, starting materials, intermediate products, and final Active Pharmaceutical Ingredient (API) based upon conformance with specifications and completion of associated documents. In addition, when shipments of final API are made, verify labeling and packaging is consistent with ASH’s SOP.


Administrative Duties:

 

Issue master production records to manufacturing, ensuring that the current version is issued. File completed batch production records, testing records, and cleaning records. Maintain change control files for master records, SOPs, and forms. Ensure that current versions of the records are properly filed and available for use by the end users.

Audits: Support internal and external audits and regulatory inspections. This may require data gathering, interviewing, or escorting auditors during an audit. Conduct internal audits and housekeeping inspections and walkthroughs of Quality Systems and related operations to ensure compliance with written procedures. Audit’s quality system and records, creating documentation as needed. Follow-up as appropriate to ensure corrective action is implemented. During an audit, participate in the audit to explain quality systems and operations. Represent systems thoroughly and positively, being receptive to the auditor’s comments. Participate in the development of a formal response to audit report as appropriate. Maintain QA retain inventory and perform annual retain inspections.


Reports/Document Management:

This may include Annual Product Reviews, Non-Conforming Material Reports, and Investigation Reports. Participate in preparation or review of associated documentation, such as Analytical Methods Validation Reports, Cleaning Validation Reports, and Process Validation Reports.
• Quality Systems Support: Support tracking of Quality System deliverables, i.e., CAPA’s, periodic document review, environmental monitoring, Quality Metrics, Quality Agreements etc. Review and approve Trackwise events related to manufacturing, laboratory, and warehouse operations. Participate in the evaluation and triage of events, deviations, CAPAs, OOS, OOT and unplanned maintenance activities. Identify and implement continuous improvements for the elements of the quality system related to manufacturing, laboratory, and warehouse operations. Contribute to the writing, coordination, review, approval and maintenance of the standard operating procedures, policies, and work instructions. Conduct Gap Assessments with corporate guidelines and regulatory requirements and develop mitigation plans
• Risk Management: Participate in the Risk Management program, including updating risk analysis, participating in applicable teams and maintaining Risk Management documents.


EDUCATION/EXPERIENCE:

Bachelor’s degree in the physical or biological sciences or engineering. Chemistry/Chemical Engineering preferred.
• Minimum eight (8) years’ experience in pharmaceutical operations, regulated life sciences, or quality assurance, or an equivalent combination of Quality and technical education and experience is preferred with 2-5 years of supervisory experience.
• Knowledge of GMP requirements (21CFR Parts 11, 210, 211, Annex 11 and ICH Q7, Q9 & Q10).
• Strong computer skills with MS Office (e.g. Word, Visio and Excel), Relational Databases, Reporting and statistical tools.
• Proficient in TrackWise, SAP and Master Control.


JOB COMPETENCIES:


• Excellent organizational and planning skills.

  • Strong written, verbal, and interpersonal communication skills.
  • Have the ability to develop, perform, evaluate, and troubleshoot within a scientific discipline.
  • Demonstrated strong analytical skills, and the ability to work independently against multiple deadlines.
  • Experience interacting with FDA or other regulatory agencies
  • Knowledge with manufacturing quality (manufacturing, packaging, facilities, critical systems, validation, SPC, etc.)

• Must complete tasks independently and notify supervisor of decisions outside of established processes.


About Azzur

Our employees are fueled by an entrepreneurial spirit and the desire to make a difference in the lives of our customers, coworkers and our partners. If you’re ready to put in the work, take personal responsibility and test the limits of what’s possible, we’re ready to provide the reward.


Do What You Love

At Azzur, we look for talented individuals who take pride in the work they do. We foster employee growth by encouraging our employees to focus on doing what they love and what they do best.

Azzur is a GxP compliance and consulting organization dedicated to providing high quality, expertly backed, assistance that drives life science companies to success. We are seeking highly motivated and talented individuals to join our incredible team of skilled problem solvers. Qualified candidates must have a desire to learn, apply, engage, and adapt in the ever-changing healthcare field while simultaneously and organically exuding Azzur’s core values:

Put Others First, Courage to Take Action, Take Personal Responsibility and Have Fun!

 

 

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