CW Product Quality Specialist

Upsher-Smith Laboratories, LLC•Maple Grove, MN

44d

About The Position

General Summary: Responsible for providing Quality support to the USL product portfolio, inclusive of products in development through product discontinuation. Represents QA on relevant project teams and provides general quality guidance to meet project milestones. Acts as Quality subject matter expert and serves as liaison with cross-functional stakeholders or third-party suppliers to facilitate continuous improvement, change management, and issue resolution. Effectively utilize quality and risk management processes/tools to ensure compliant and efficient processes. Description of Essential Duties: Provide Quality guidance and expertise to facilitate product changes and issue resolution. Collaborate to ensure facilities/ utilities meets industry standards. Provide support to the Technical Services, Operations, Regulatory Affairs, and Materials Management groups to promote continuity of product lifecycle management. Create and revise SOPs as needed. Review and approve product-related documents including, but not limited to, specifications, master batch records, process validation, change control documents, CAPA, investigations, deviations, regulatory submissions, and stability protocols. ' Assists Operations in situations requiring deviations/investigations. Assists with internal audits, quality audits, and facility audits. Utilize risk analysis to assess product impact and determine corrective/ preventative actions. Utilize technical writing skills to ensure clear, concise investigation summaries. Performs executed batch record reviews and product disposition of finished product during product development and/or internal commercial operations. Responsible for customer complaint investigations and various GMP records (i.e. SOPs, deviations, etc.). Stays abreast of national and international industry and regulatory trends relating to quality; ensures that USL systems are administered in compliance with those policies and regulations providing subject matter expertise. Review and provide input to department operational procedures and practices pertaining to compliance with corporate standards, quality systems, SOPs and cGMPs. Collect data for department metrics. Perform Quality Assurance activities associated with commercial products, ensuring accuracy and integrity of all data submitted to applicable regulatory bodies. Responsible for review regulatory submission documents. Review and approve equipment qualification documents (i.e. IQ, OQ, PQ, URS/FS optimization, maintenance and calibration, etc.)

Requirements

Bachelor’s degree with 4 years of experience required in a GMP-related industry (Pharmaceutical or Medical Device).
Broad working knowledge of Quality Systems (e.g change controls, CAPAs) and regulatory compliance programs required.
Excellent interpersonal, organizational, typing and proofreading skills required.
Ability to work independently or in a team; ability to perform detailed work; ability to work under tight time constraints.
Ability to prioritize work for self and influence others for action as required.
Strong computer skills required (knowledge of word processing, spreadsheet and data base software recommended).
Knowledge of SAP or other ERP software strongly recommended.

Nice To Haves

Quality Assurance experience preferred.
ASQ certification a plus.

Responsibilities

Provide Quality guidance and expertise to facilitate product changes and issue resolution.
Collaborate to ensure facilities/ utilities meets industry standards.
Provide support to the Technical Services, Operations, Regulatory Affairs, and Materials Management groups to promote continuity of product lifecycle management.
Create and revise SOPs as needed.
Review and approve product-related documents including, but not limited to, specifications, master batch records, process validation, change control documents, CAPA, investigations, deviations, regulatory submissions, and stability protocols.
Assists Operations in situations requiring deviations/investigations.
Assists with internal audits, quality audits, and facility audits.
Utilize risk analysis to assess product impact and determine corrective/ preventative actions.
Utilize technical writing skills to ensure clear, concise investigation summaries.
Performs executed batch record reviews and product disposition of finished product during product development and/or internal commercial operations.
Responsible for customer complaint investigations and various GMP records (i.e. SOPs, deviations, etc.).
Stays abreast of national and international industry and regulatory trends relating to quality; ensures that USL systems are administered in compliance with those policies and regulations providing subject matter expertise.
Review and provide input to department operational procedures and practices pertaining to compliance with corporate standards, quality systems, SOPs and cGMPs.
Collect data for department metrics.
Perform Quality Assurance activities associated with commercial products, ensuring accuracy and integrity of all data submitted to applicable regulatory bodies.
Responsible for review regulatory submission documents.
Review and approve equipment qualification documents (i.e. IQ, OQ, PQ, URS/FS optimization, maintenance and calibration, etc.)