Skip to content

Job Openings

Quality Assurance Specialist

Columbus, OH 43228

Posted: 10/18/2022 Employment Type: Contract Job Category: Quality and Compliance Job Number: 517830 Country: United States Is job remote?: No

Job Description

Duties:    
  • Partners with Third Party Quality Management (3PQM), Contract Manufacturing Organizations (CMOs), and OPUs to ensure that complaints are properly investigated and accurately documented within the global complaint system. 
  • Ensures the root cause or most probable root cause of reported complaint has been determined
  • Collaborates with OPUs, 3PQM and CMOs as needed to review and/or recommend sustainable Corrective Action/Preventive Actions (CAPAs) to be implemented at impacted sites.
  • Reviews, approves/closes customer complaints ensuring that the investigation meets acceptable quality standards including but not limited to established timelines. Focus is on complaints with market action potential, however, will also support closure of other complaint investigations as needed.
  • Supports international Quality initiatives/projects.
  • Acts as Local Pharmaceutical Complaint Officer (LPCO).
  • Ensures that all complaints received at the local level are entered into the company's complaint system, categorized, and assigned to the appropriate investigation site within established timelines including interaction with the complainant, the Corporate Pharmaceutical Complaint Officer and potentially with local health authorities; regularly performs complaint trending and issues complaint reports. 
  • Collaborates with other LPCOs and Deputy LPCOs on global continuous process improvement initiatives.   
  • Represents  at internal and external forums on complaint management.
  • Responsible for complaint trending evaluation, leads functional team meetings to ensure that Critical Events are known to local Quality management.
  • Provides complaint data to and participates in monthly cross functional Quality Management Review (QMR) meeting and monthly 3PQM QMR to ensure site is aware of complaints within US Marketed products.
  • Collaborates with others within Quality Assurance to ensure complaint process is of high quality and adheres to established timelines.
  • Actively participates in alignment calls with HPSG, and Complaint MSO to drive continuous process improvements.
  • Acts as local contact partner/liaison for Brand Safety & Security initiatives.
  • Makes determination when to escalate to Quality Commercial Quality and local Quality management.
  • Responsible for complaint trending evaluation, leads functional team meetings to ensure that Critical Events are known to local Quality management.
  • Independently performs batch record review and/or final disposition of drug products manufactured by CMOs and BI OPUs ensuring that the batch was produced in compliance with specifications, cGMPS and corporate policies and procedures.
  • Possesses the authority to make batch disposition (approval to distribute, reject) decisions and address non-standard events and documentation errors with CMOs.   Errors in decision making can result in market action such as product recall and/or interruption in the supply chain, therefore ability to meet the market demands.

Skills:    
  • Ability to respond and act appropriately with all levels under time pressure and regulatory scrutiny.   For example, ability to evaluate quality issues and make strategic decisions to minimize the quality and business impact of product batches and campaigns.   Escalates and collaborates with quality management to resolve trends impacting product quality.
  • Demonstrated knowledge of FDA, cGMP, EU regulations, and USP.   Emphasis on management of current good manufacturing practices programs.
  • Demonstrated effectively applying cGMP and quality system regulations within the pharmaceutical industry. 
  • Demonstrated knowledge of Quality Assurance, Production, Laboratories or Regulatory functions within a pharmaceutical environment.
  • Excellent communication skills with the ability to influence/persuade individuals. 
  • Ability to utilize active listening skills to understand the concerns or reasoning to be responsive, gain trust, and build strategic relationships.
  • Project management expertise to arrive at quality effective and efficient processes that contribute to product quality.
  • Experience using Microsoft applications (Word, Excel) and ERP is preferred.
  • Demonstrated investigative techniques to uncover problem areas and recommend corrective actions.  
  • Problem solving ability requiring attention to detail, accuracy, cGMP, and scientific judgment.

Education:    
  • BS/BA in Chemistry, Pharmacy, or related science Diploma with additional years of experience.
  • Minimum five (5) years’ experience with BS/BA pharmaceutical in an area that provides a knowledgeable background for compliance, quality orientation, QA, or manufacturing document review experience.
  • Diploma and seven (7) years’ experience in pharmaceutical in an area that provides a knowledgeable background for compliance, quality orientation, QA, or manufacturing document review experience.
Apply Online

Send an email reminder to:

Share This Job:

Related Jobs:

Login to save this search and get notified of similar positions.
Social Share Buttons and Icons powered by Ultimatelysocial