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Purdue Pharma L.P. · 21 hours ago

Sr. Quality Specialist I, Documentation Systems

Wilson, NC

Part-time

Onsite

Senior Level

6+ years exp

Purdue Pharma L.P. is dedicated to developing and marketing medications to meet the evolving needs of healthcare professionals and patients. The Sr. Quality Specialist, Documentation Systems is responsible for conducting quality compliance activities, managing documentation, and supporting regulatory submissions within the organization.

BiotechnologyHealth CarePharmaceutical

No H1B

Responsibilities

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

Qualification

Quality SystemsGxP regulationsSOP authoringDocumentation managementData analysisComplaint investigationsChange controlVeeva QMSProblem resolutionTeam collaboration

Required

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

Company

Purdue Pharma L.P.

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Purdue and its subsidiaries develop, manufacture and market medications to meet the evolving needs of healthcare professionals, patients, and caregivers.

Founded in 1892

Stamford, Connecticut, USA

501-1000 employees