Sr. Quality Specialist , Documentation Systems

Job Summary

The Quality Assurance (QA) Sr. Quality Specialist, Documentation Systems is a position that encompasses several Quality Systems. The position conducts technical quality compliance related activities in accordance with GxP regulations and internal Standard Operating Procedures. Primary responsibilities include conducting product complaint investigations, administration of site change control program, compiling of annual product reviews, coordinating documentation in support of global submissions, routine document revisions, document issuance, and documentation archives.

• Perform complaint investigations for Purdue manufactured products and work closely with Supplier Quality Assurance to obtain required 3rd party investigative details, as required.
• Escalate product complaints as deemed necessary for field action and prepare field alerts as applicable.
• Author and/or review and implement SOPs to ensure compliance with current Purdue standards and cGMP as related to areas of responsibility.
• Compile, review, and facilitate approval of Annual Reports and Annual Product Reviews.
• Assist with administration of site Change Control Program.
• Assist with the generation of monthly and quarterly metrics as required by SOPs and review metric reports to ensure the appropriate metrics are being captured.
• Assist with administration of the electronic documentation management system.
• Ensure that documentation is maintained/archived in accordance with internal procedures and regulatory requirements (i.e., GxP, etc.).
• Compile global regulatory submission certifications and documentation as required by business partners for ex-US submissions.
• Provide support with product and process investigations and data analysis, as requested by Quality management.
• Utilize knowledge of regulatory requirements to identify, describe, and communicate issues and participate in problem resolution and corrections.
• Issue of documents, including but not limited to Master Batch Records, Write-up Pages, Logbooks and Lab Notebooks.
• Participate in resolving deviations associated with the Documentation Systems group.
• Participate in the management of the document periodic review process.
• Support and maintain an environment that fosters communication and teamwork within Quality Assurance and related departments.
• Process documents and requests using applicable quality systems.
• Maintain current knowledge base within relevant technical disciplines of FDA regulations and awareness of the necessity and impact of compliance of the business.
• Communicate and participate in identified improvements as well as mitigation of potential gaps.
• Support regulatory inspections, as necessary.
• Perform other related assignments and duties as required and assigned.

Bachelor’s degree required and 6 years minimum relevant experience in supporting and maintaining quality systems, or equivalent level of experience in pharmaceutical or related industries; or graduate degree (MS preferred) with 4 years minimum relevant experience.

• Demonstrated sound understanding well developed working knowledge and ability in primary discipline.
• A thorough understanding and working knowledge of Quality Systems and tools.
• Knowledge of GxP regulations in other disciplines and awareness of impact on cross functional areas.
• The ability to recognize changes in priorities and plan as needed; to look for opportunities arising out of changing parameters.
• The ability to effectively identify and communicate challenges and their impact in a timely manner and participate in problem resolution.
• The ability to provide guidance to personnel from a wide range of departments related to complaint investigations, change controls, annual product reviews, documentation issuance, handling and archival, and Veeva QMS and DMS.

The incumbent reports to the Associate Director, Quality. The position has no direct supervisory responsibility, however, the incumbent must:

• Possess the ability to independently prioritize workload.
• With minimal guidance and supervision, conducts routine and non-routine…