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Quality Analyst (P-1032),

Cincinnati - USA
Date Posted: 7/9/2013

(2 QA Positions: 1 M-F and 1 Weekends)

Duties and Responsibilities:  

  1. Responsible for conducting investigations into quality deviations of batches, preps, lots, out of specification lab results, equipment, and facilities to ensure all cGMPs, SOPs, product registrations, and client requirements are met.  This individual must be able to investigate deviations and assist in determining the probable root cause of the incident and corrective action. This individual will be expected to make recommendation of batch approval/rejection based on the results of the quality investigation, assist in determining steps necessary to resolve problem batches, as well as follow-up to assure corrective actions are implemented. In addition, Responsible for the timely closure of investigations.
  2. Assesses event impact and risk to product, lot, facility, patients and process. Classifies criticality of event (critical vs. non-critical). Provides guidance to Manufacturing to ensure compliance with all applicable regulations and drives timely resolution of GMP issues.
  3. Provides guidance and control directives to Manufacturing regarding remediation activities required to continue production. Authorized to suspend manufacturing operations when situations warrant.
  4. Assists Manufacturing in evaluating batch release documentation against current manufacturing regulations and site procedures. Provides guidance in determining whether a deviation (or other remediation) is required prior to release.
  5. Performs tasks/deviations/investigations/protocols/IQ, OQ, and PQ’s; The incumbent may also be involved in the review and approval of various Operation documents such as cleaning validation documents, change control requests, etc.
  6. Works closely with other members of Manufacturing and Quality in a specified area to recognize opportunities for improvement and illicit change through the use of Patheon’s Change Control processes, CAPA system, etc.
  7. Participates in inspection readiness activities and may also be involved in inspections by regulatory agencies.
  8. Models effective and constructive communication behaviors and interactions with technical departments both orally and in writing; maintain acceptable proficiency in technical and non-technical (e.g. interpersonal) skills.
  9. Requires attention to detail, good organizational skills, and a sound understanding of cGMPs and Manufacturing.
  10. Assists with the development of CAPA’s and collaborates with stakeholders to ensure all necessary activities are executed timely and effectively.
  11. Escalates critical events and investigation findings to Management.
  12. Represents the Quality Assurance group on various project teams such as validation, engineering phase review meetings, and daily department communication meetings. May also assist in developing and maintaining various quality systems and programs..
  13. Requires interaction with Process Engineers, Records/Release, QA Management, Quality Control, QA Regulatory, Engineering, PDS, and Manufacturing. 

Requirements:

Three to five years of experience in Quality Assurance, Quality Control and/or in a pharmaceutical Manufacturing (FDA regulated) industry. Incumbent must have a good working knowledge of cGMP’s.  Must have sound problem solving skills, good verbal and written communication skills. Must be able to manage and prioritize daily tasks with minimal supervision. Must be capable of using Microsoft Office, Word, Excel, and Power Point. Must have working knowledge of Trackwise, SAP, and LIMS. Independent decision making capability and ability to think conceptually and understand impact of decisions. Hard working and productive in an autonomous environment. Very good conflict resolution and negotiation skills. Good organization skills resulting in the ability to be self-directed and manage multiple projects. Emerging leadership and mentoring skills.  Respectful interactions with individuals with diverse views or backgrounds. 

Education Required:

BS Degree in:  Pharmacy, Chemistry, Engineering or other related Scientific Majors.

EEO/AA Employer/Vet/Disabled

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Quality Analyst (P-1032),

Cincinnati - USA

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