Lead Quality Assurance Specialist - Operations

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Location

Chelsea, MA, United States

Summary

The Lead Quality Assurance Specialist – Operations, Day Shift is responsible for supporting operations in a GMP Manufacturing Facility. This individual supervises the work of QA Specialists and Senior QA Specialists on the Operations team. 

Full Description

The Lead Quality Assurance Specialist – Operations, Day Shift is responsible for supporting operations in a GMP Manufacturing Facility. This individual supervises the work of QA Specialists and Senior QA Specialists on the Operations team. 

*Essential Duties and Responsibilities include the following. Other duties may be assigned.

  • Primary Department Lead for Oversight of production activities, including area clearance, issuance and review of batch records, and making decisions on initiation of Discrepancies
  • Oversight, review, and approval of Materials Management and Supply Chain activities
  • Collaboration with cross-functional teams such as Manufacturing, Engineering, and Materials Management on timelines, production or facility related Events, and change controls.
  • Primary Department Lead for Management and Oversight of Environmental Monitoring Program (and contract laboratory) for Chelsea Facility, including Controlled Environments and Clean Utilities
  • Management of metric generation and reporting on the state of control of the Controlled Environment and Clean Utilities for the Chelsea Manufacturing Site
  • Management of metric generation and reporting on Quality Metrics for production related events
  • Revision and/or review and approval of SOPs, Protocols, Reports, and Master Batch Records for continuous improvement
  • Initiation, review, approval, and trending of Discrepancies, including Deviations and Investigations.
  • Support of implementation of CAPA and review of CAPA effectiveness as determined through Discrepancies
  • Support review and implementation of Change Controls
  • Review and approval of Certificates of Analysis for Raw Materials, Intermediates, and Finished Goods
  • Disposition of controlled materials (Work in Progress, Finished Product, and Raw Materials)
  • Final release of product including Certificate of Conformance and approval for Distribution of product
  • Provide support during compliance inspections conducted by external sources (i.e. health authorities)
  • Active member of a self-directed work team with operations personnel to critically evaluate and continuously improve manufacturing control systems

Education and/or Experience:

  • Bachelor’s degree in a scientific discipline is required, preferably in physical Science or Chemistry.
  • Minimum of 7-10 years of progressive experience in a GMP environment required.
  • Minimum of 7 years of Quality Assurance experience in support of GMP production required.

Supervisory Responsibilities:

  • Supervision of team of QA specialists of various roles/responsibilities, including both batch production support, Environmental Monitoring, and Quality Systems support.

Qualifications:

  • Working knowledge of GMPs and their application to pharmaceutical manufacturing required.
  • Knowledge of FDA guidance documents is required.
  • Knowledge of current FDA trends and use of FDA website tools required.
  • Previous exposure to investigations and product complaints required.
  • Must be able to interpret applicable standards and objectively make decisions.
  • Microbiology/Environmental Monitoring background preferred by not required.

Computer Skills:

  • Must be proficient in MS Office Suite.
  • Experience in the use of Material Requirements Planning (MRP) systems preferred.

Certificates, Licenses, Registrations:  none required

Other Skills and Abilities:

  • Excellent verbal and written communication skills.
  • Ability to manage both day-to-day operations as well as project work in a fast paced environment.
  • Ability to work both independently and in a collaborative team setting.
  • Ability to accept multiple tasks and adjust priorities, as assigned.
  • Demonstrated ability to stay abreast of trends and new information in the profession.
  • Excellent organizational skills and attention to detail are required.

Physical Demands:

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

  • This position requires minimal travel; average travel for this position is 5-10% with some variation based upon the demands of the business imperatives.

Work Environment:

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job.

No specific work demands.

*To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed above are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.