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Specialist/Senior Specialist, QA GMP Operations

Kiniksa Pharmaceuticals – Lexington, MA

The Specialist/Senior Specialist, Quality Assurance (QA) will report into the QA GMP Operations team lead and will support cGMP activities in the internal CMC Manufacturing Laboratory and at Contract Manufacturing Organizations, functioning as a Person-in-Plant as needed. The candidate will ensure Batch Reviews and associated Quality Processes (e.g., deviations, CAPA, change control, protocols, etc.) are progressed in a compliant and timely manner and ensure cGMP compliance is maintained. The candidate will work with cross-functional teams to identify and implement meaningful corrective actions arising from deviations and audit observations.

Job Responsibilities:

Under direction from and in collaboration with the GMP Operations team lead, the Specialist/Senior Specialist:

  • Reviews and approves complex manufacturing batch production and analysis records in support of product disposition in accordance with specifications and SOPs.
  • Provides quality assurance guidance and recommendations in a professional and collaborative manner to internal and external stakeholders.
  • Monitors various stages of batch processing, on shop floor as needed.
  • Drafts and reviews specifications and SOPs.
  • Reviews and approves quality systems associated with internal and externally produced or tested biologics products (discrepancy reports, investigations, CAPAs, Change Controls, etc.)
  • QA support for incoming materials activities.
  • Provides QA support to contact manufacturing operations (attend meetings, person-in-plant review and approval of CMO documentation.)
  • Assures Change Control activities are implemented according to approved plans.
  • Evaluates the effectiveness of CAPAs and other changes.
  • Monitors and trends batch record errors, provides management with quality indicator data, and collaborates with stakeholders to reduce sources of error.
  • Supports analytical method qualification, method transfer, and lab investigations.
  • Applies strong technical expertise of QA/QC and Manufacturing processes to support development and maintenance of cGMP compliant quality systems.

Education and Experience:

  • Knowledge of science generally attained through studies resulting in a B.S. in science, engineering, biochemistry or related discipline, or its equivalent is preferred.
  • A minimum of 4 years of relevant experience in a GMP environment with at least 1 year focused on product quality.
  • Working knowledge of US and EU cGMP regulations and guidance.

Competency Expectations:

  • Knowledge of biotech bulk and finished product manufacturing, and analytical testing is required.
  • Independently troubleshoots problems and issues; called upon to train or assist others for a large portion of the job.
  • Provides consistently prompt, efficient, dependable, highly skilled service.
  • Demonstrates consistent judgment, quality, accuracy, speed, and creativity.
  • Detects and resolves problems; assists others with problem resolution; misjudgment may jeopardize compliance.
  • Understands, selects, and uses appropriate risk management and root cause analysis tools.
  • Takes initiative in making improvement suggestions to promote operational goals.
  • Applies Quality concepts and company policies to resolve issues of moderate complexity in an effective manner.
  • Reflects solid understanding of strategies and goals and can take part in major parts of projects or provide expert service.
  • Recommends improvements to on-going processes and projects.
  • Facilitates designing processes with Quality built in from the beginning.
  • Identifies, and uses good judgement to handle out-of-compliance situations.
  • Executes policies, practices, and compliance requirements.
  • Good listening and communication skills.
  • Positive approach.
  • Proficient in the use of Microsoft Office.

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