Senior Quality Assurance Specialist

• This position is primarily responsible for providing Quality Assurance oversight of the manufacturing, packaging and testing of finished pharmaceutical products that are produced for Purdue by third party contract manufacturers and packagers.
• Responsibility also includes internal audit of Purdue manufacturing facilities.
• Responsible for planning and coordinating compliance audits and quality systems assessments thereby ensuring compliance with all applicable processes, systems and provisions of the Quality System.
• Conducts and/or provides oversight of audits of contract manufacturing/packaging organizations, contract testing laboratories, API suppliers, excipient suppliers, product distribution centers, packaging component suppliers, printed component suppliers and other suppliers as deemed necessary per Purdue requirements.
• The incumbent is responsible for assuring that Purdue's products that are produced at external manufacturing and packaging facilities as well as raw material, component and API suppliers for Purdue internally produced products meet all federal and other applicable regulations and Purdue Quality Standards.
• Responsibilities also include audits of raw material, component and API suppliers for Purdue internally produced products, and occasional performance of audits as a part of due diligence activities supporting New Business Development.
• This position is primarily responsible for providing Quality Assurance oversight of the manufacturing, packaging and testing of finished pharmaceutical products that are produced for Purdue by third party contract manufacturers and packagers.
• Responsibility also includes internal audit of Purdue manufacturing facilities.
• Responsible for planning and coordinating compliance audits and quality systems assessments thereby ensuring compliance with all applicable processes systems and provisions of the Quality System.
• Conducts and/or provides oversight of audits of contract manufacturing/packaging organizations, contract testing laboratories, API suppliers, excipient suppliers, product distribution centers, packaging component suppliers, printed component suppliers and other suppliers as deemed necessary per Purdue requirements.
• The incumbent is responsible for assuring that Purdue's products that are produced at external manufacturing and packaging facilities as well as raw material, component and API suppliers for Purdue internally produced products meet all federal and other applicable regulations, and Rhodes/ Purdue Quality Standards.
• =Responsibilities also include audits of raw material, component and API suppliers for Rhodes/Purdue internally produced products, and occasional performance of audits as a part of due diligence activities supporting New Business Development.

• Eight years (MS candidate) to ten years (BS candidate) minimum experience or equivalent level of experience in pharmaceutical or related technical Operation/Quality experience.
• Necessary Knowledge, Skills and Abilities:
• Strong knowledge of cGMPs and experience in GMP processes and pharmaceutical document review to understand and guide suppliers with quality/technical/documentation issues. Of particular importance is understanding of production processes and equipment, validation, stability and OOS guidances.
• Ability to develop good interpersonal skills and create rapport with third party site personnel
• Ability to manage several projects simultaneously and to address unexpected results.
• ASQ CQA certification preferred.
• Background in working with external suppliers a plus to demonstrate understanding of relationship management and appropriate use of boundaries.
• Excellent written and verbal communication skills required.
• High proficiency with software applications like Excel and Word required.
• Experience with SAP and TrackWise a plus as Purdue Quality Systems are TrackWise and SAP based.
• Multi-tasking is an essential requirement of this job and thus strong organizational skills are required to ensure appropriate tracking, closure and extension of all tasks as appropriate.
• Bachelor's degree with 8-10 years of experience in Quality Assurance within Pharmaceutical industry.
• ASQ CQA Certification preferred.
• High proficiency with with MS-Excel and Word.
• Experience with SAP is required.

Katalyst Healthcares & Life Sciences