Job description

Requirements

  • Entry level
  • No Education
  • Salary to negotiate
  • Hillsboro

Description

Main Purpose
Manage and lead complaints with minimal guidance. Ensure investigation action plans and final investigation summaries are accurate, include appropriate corrective actions, and follow company standards. Collaborate with departments to establish appropriate, efficient, and timely investigation strategies. Also manage and lead product investigations with the same rigor and intent, on an as needed basis.
Key Responsibilities
Follow company policies and procedures. 
Maintain a state of inspection readiness. 
Provide input on performance accountabilities and departmental objectives.
Establish work priorities to meet targets and timelines and effectively manage competing priorities, with appropriate escalation.
Ensure appropriate application and integration of cGMPs in the product complaints management system.
Complete responsibilities on-time and in-full to support the on-time completion of batch disposition per Roche ATL.
Develop solutions to product complaint issues and Quality initiatives with inter-organizational impact following cGMP regulations and Genentech standards.
to independently address complex problems.
Identify, design, and implement department or cross-functional business process improvements.
Collaborate with key stakeholders to foster effective interdepartmental and cross-functional partnership solutions.
Apply extensive theoretical and cross-functional expertise in the context of company objectives
Collaborate with multiple internal and external groups (e.g. Affiliates, Manufacturing, Internal Quality functions and External Quality) to ensure product quality and compliant processes are consistently produced/followed in accordance with Roche Policies and Procedures.
Participate in cross-functional meetings to support site goals and production performance in accordance with Key Performance Indicators (KPI).
Lead and participate in root cause analysis and present at QRB.
Inform management of critical product complaints and with cross-functional support, provide time impact assessments of potentially affected products, materials or processes.
Generate summaries in support of Annual Product Quality Reviews
Analyze complaint information and identify potential Quality issues including performing trend analysis, as required.
Assess the accuracy of root cause determinations based on a thorough evaluation of possible failure modes.
Complete product complaint investigation reports and supporting documentation.
Present product complaint records and/or reports during periodic audits and regulatory inspections.
Train internal customers on relevant business processes.
Key Interfaces:
Manufacturing, Local MSAT, Planning, Tank Management, Warehouse and Distribution Center
Quality Functions (Quality Control, External Quality, Quality Systems, Quality Compliance. Lot Disposition)
Roche Complaint management network
PQS document owners/authors (e.g. PTQG)
Pharma Technical Regulatory
Health Authorities
Other global functions, as required
Qualifications
 B.A. or B.S. degree (preferably in Life Science); Master’s degree preferred
 Seven to ten years relevant experience in a Quality role in the pharmaceutical or biopharmaceutical industry; or an equivalent combination of education and experience
Knowledge/Skills/Competencies:
Knowledge of Quality System and QA principles, practices and standards for the pharmaceutical industry
Good knowledge of cGMP relevant to the pharmaceutical industry
Good knowledge of pharmaceutical, biotechnology or medical device related product operations including local and international quality regulations.
Some knowledge of regulations for combination product (applicable for Drug Product and Finished Goods) preferred.
Good conflict management skills
A comprehensive knowledge of the Quality Mgmt. System leading to effective decision making capabilities across multiple functional areas
Strong communications skills including the ability to frame messages clearly and concisely
Demonstrated excellent verbal and written communication skills
Ability to interpret and relate Quality Standards for implementation and review
Effectively interacts with senior-level personnel on significant issues.
Sound decision-making skills

About the company

Roche is a Swiss global health-care company that operates worldwide under two divisions: Pharmaceuticals and Diagnostics. Its holding company, Roche Holding AG, has bearer shares listed on the SIX Swiss Exchange.

The company headquarters are located in Basel and the company has many pharmaceutical and diagnostic sites around the world – including: Tucson, AZ; Pleasanton, CA; Vacaville, California, Oceanside, California, Branchburg, NJ; Indianapolis, Indiana; Florence, South Carolina; and Ponce, Puerto Rico in the US; Welwyn Garden City and Burgess Hill in the UK; Clarecastle in Ireland; Mannheim and Penzberg in Germany; Mississauga and Laval in Canada; Shanghai in China; Mumbai & Hyderabad in India; São Paulo and Rio de Janeiro, Brazil; Segrate, Milan in Italy; Johannesburg in South Africa; Karachi, Islamabad and Lahore in Pakistan. There are 26 manufacturing sites worldwide.

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