1 hour

QA Investigator

Sebela Pharmaceuticals Inc.
Holbrook, MA 02343

















SUMMARY OF POSITION


Administers the Holbrook Customer Complaint System. Works with other departments as needed to investigate deviations, incidents and other quality-related problems and identify root cause. Provides support in the generation of quality investigation drafts that are complete, comprehensive, and presentable to FDA upon approval of Quality Management. Verifies the accuracy, quality and effectiveness of all corrective actions taken in response to quality investigations. Supports the Internal and External Audit function as needed.


MAJOR ACTIVITIES AND RESPONSIBILITIES



  • Administrator of the Customer Complaint system at the Holbrook Facility.

  • Investigates all Customer Complaints received at Holbrook documenting the activities on relevant forms for submission to Senior Quality Management for approval.

  • Facilitates the resolution of quality investigations, following direction under minimal supervision.

  • Reviews investigations, provides assistance to resolve compliance risks and prepares final reports to close-out investigations.

  • Exercises good judgment on need to escalate potential issues to senior management.

  • Works closely with Manufacturing, QC Laboratory, Engineering and Quality Assurance applying critical thinking to all investigations to assure reports are complete, clearly written and conform to SOPs to meet FDA expectations.

  • Makes independent decisions and acts with authority to carry out actions, in adherence with department policy.

  • Drafts Inspection Protocols and assume leadership role in Product Inspections.

  • Provides leadership and direction in Investigation corrective actions by involving teams of cross functional representatives.

  • Reports to Senior Management on manufacturing processes, coordinates QC testing requests and sample management, and notifies senior management immediately regarding any potential critical issue.

  • Tracks investigations to ensure completion according to established timelines and identify potential adverse trends, supporting continuous improvement initiatives.

  • Perform other duties as needed and assigned (including but not limited to internal and external audits, training initiatives, review and approval of validations, change controls, OOS/OOT reports and calibrations)

  • Provides backup support for other managerial staff in the department as needed.

  • Participates in Regulatory facility audits.



SCOPE MEASURES



  • The QA Investigator will sign as the performer of Quality documents within their purview and will act on behalf of the management represented. 



BACKGROUND REQUIREMENTS



  • Associates Degree or 3 years in FDA-regulated industry

  • Knowledge of QA/QC, Manufacturing and Validation following cGMPs.

  • Strong Technical Writing and computer skills.

  • Ability to interact effectively between multiple departments with competing demands.





 

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Posted: 2022-05-20 Expires: 2022-06-19

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QA Investigator

Sebela Pharmaceuticals Inc.
Holbrook, MA 02343

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