Valeant Pharmaceuticals

Sr. Quality Specialist

US-SC-Greenville
Job ID
9712
Pos. Category
R&D
Pos. Type
Full Time

Overview

Valeant Pharmaceuticals International, Inc. is a diverse and decentralized pharmaceutical company that is committed to focusing on our key stakeholders while delivering consistently high performance. Our values provide the overall direction for our company, and provide us with the tools necessary to rise to any challenge by leveraging our collective hard work and effort along with our unwavering competitive spirit. These values help us set goals based on our organization’s potential and what we hope it will become.

 

Reporting directly to the Manager, Quality Systems & Compliance (QSC), this role is responsible to perform routine Quality System tasks as assigned and lead/execute various Quality System improvement projects. This position also provides back-up support for the QSC Manager, as needed.

 

This role works in the areas of documentation systems, NC/RCCAPA administration, nonconformance investigations, compliance, internal and supplier audits, and provides support for regulatory readiness/audits.  Responsible for executing against strategic goals and supporting the objective to maintain site level performance metrics.  Responsible for providing general leadership in relation to Quality Systems. Routine interaction with the site employees, Bausch & Lomb employees at other sites, vendors and regulatory authorities to provide resolution to requests for information, issues, and collaboration of project work. 

Responsibilities

  • SAFETY: Demonstrate safety performance behaviors and engage actively to promote.
  • COMPLIANCE: Conducts internal and supplier audits as needed.  Supports regulatory and third party inspections for the site.  Interfaces with outside regulatory and legal authorities as appropriate.  Write, review, revise and approve procedures and specifications, as needed.  Provide oversight for various quality system elements and tools.  Works with quality, operations, distribution to ensure sound and timely decisions/investigations are made/written regarding nonconformance and root cause, CAPA analysis.
  • MANAGING, PLANNING & DIRECTING: Manage the CAPA system and associated CAPA board. Execute assigned goals to support strategic quality and site objectives.  Promote open communications within the site and with external contacts.  Lead and execute various projects to enhance the site’s quality systems.  Provide quality systems assistance for site functions.  Review/approve investigation reports.
  • CONTINUOUS IMPROVEMENT: Maintain and continually improve quality documentation systems.  Identify, evaluate, select and implement against continuous improvement and compliance initiatives.  Evaluating and upgrading procedures, policies, specifications and other regulated documentation.  Write/review/approve SOPs.   

Key Relationships: 

  • Internal customers include all departments within the organization.
  • External partners include regional / global quality counterparts, regulatory bodies, independent inspectors, and customers.

Qualifications

Education: 

  • Minimum of a B.S. degree, scientific or technical degree preferred. 
  • Specialized training in 21CFR211, 21CFR820, ISO 9001:2000, ISO 13485 is preferred. Certifications in the following highly desirable (CQA, CQE, CQM, CSSBB, CPIP)
  • Experience in SAS, JMP, Statistical tools such as Minitab preferred
  • Experience in database applications (e.g. Excel, Access) required.

 

Experience:

  • Minimum of 5 years’ experience in a Quality Assurance role within an FDA regulated manufacturing or distribution facility required.
  • Professional/management experience required either in a quality systems/compliance role or a manufacturing quality assurance role in a device/drug facility.
  • Experience as an internal or external auditor and in conducting investigations is preferred.
  • Experience with automated quality systems (e.g., document management, nonconformance/CAPA management, change control, etc.) is preferred
  • Special Skills:
  • Demonstrated technical writing ability.
  • Strong analytical skills.
  • Ability to assertively interact with people at all levels of the organization.
  • Prefer an individual that has been formally trained in statistical process control.  Six Sigma GB / BB are strongly preferred.
  • Preferred Skills:  Strong organizational and communication skills required in order to develop programs, work independently with minimal supervision and effectively interact with all levels of the organization, including suppliers.  Excellent time management skills.  Demonstrated technical writing and proficiency with Excel and Microsoft Word

Be Aware of Recruiting Fraud

Valeant is an EEO/AA employer M/F/D/V.

 

Job Applicants should be aware of job offer scams perpetrated through the use of the Internet and social media platforms.

 

To learn more please read Valeant’s Job Offer Fraud Statement.

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