Halo Pharmaceuticals

Specialist, Quality Assurance

US-NJ-Whippany
Type
Regular Full-Time

Overview

This position supports the investigation process, customer complaints and Annual Product Reviews (APR); through the quality review and approval of technical documents and investigations (laboratory, manufacturing, packaging and storage) associated with Investigation Reports (IR), Customer Complaints, and associated Corrective Action Preventive Action (CAPA).  With regard to the site investigation process, the individual will: (a) provide quality, compliance and technical feedback with regard to the investigations, (b) will approve investigations on behalf of QA (when thorough and complete), and (c) will issue Action items and / or CAPAS as applicable to the investigation / complaint.  Additional responsibilities will include supporting the generation of APRs and the review of APRs prior to internal circulation for Halo approval.  Responsibilities will include supporting the trending associated with IRs, Complaints, Key Process Indicators (KPIs) and / or other Quality Metrics associated with the TrackWise Investigation Process.

Ancillary responsibilities include supporting regulatory and customer audits; as well as interacting with the customer to resolve / mitigate issues and concerns related to investigations and corrective action. 

Responsibilities

ESSENTIAL FUNCTIONS

  • Track, monitor, and close Investigation Reports, Customer Complaints, and Corrective Action Preventive Action documents and spreadsheets.
  • Prepare trending reports to include with IRs, Customer Complaints, and related Quality Metrics.
  • Review, comment and respond to customer complaints in a timely manner.
  • Review, rewrite (where applicable), comment and approve internal investigations.
  • Support the preparation of APR reports including creation of tables, graphs and compiling information; and review APR reports generated by other people within the group.
  • Prioritize projects to assure commitments are provided to customers within a respectable time frame in order to support the escalation of notification (where applicable to the nature of the complaint).
  • Ensure all work (i.e. investigations, complaints, action items, follow ups, etc.) is performed and documented accurately, timely and in compliance with internal procedures.
  • Interact with all levels of the organization.
  • Support the maintenance and update of the Quality Compliance department databases.
  • Support the generation of Quality Metrics and KPI as applicable to the scope of responsibilities within the position.
  • Assure spreadsheets are current and available for IR/CAPA meetings.
  • Send documents to customer counterparts (internal and external), on time and within the predefined due dates.
  • Participate in audits; customer, internal, external, as well as regulatory inspections.
  • Backup for the group Manager when the group Manager is out of the office.
  • Handle special projects or assignments as directed by Quality Management team.
  • Other duties as assigned.

Qualifications

POSITION QUALIFICATIONS

  • Solid knowledge of quality assurance procedures, cGMP and documentation.
  • Must be well organized and detail oriented
  • Strong computer experience
  • Knowledgeable using Excel, JMP and Microsoft Word.
  • Excellent communication (written and verbal) and interpersonal skills.

 

EDUCATION:  

  • B.S. degree in a science or engineering based field is preferred.

EXPERIENCE:

  • 3+ years in quality assurance experience in the pharmaceutical industry; minimum of 2 years of supervisory/lead role experience required.

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