Responsible for providing Quality support to the USL external and third-party product portfolio, inclusive of products in development through product discontinuation. Represents External Quality (EQ) on relevant project teams and provides general quality guidance to meet project milestones. Acts as Quality subject matter expertise based upon product portfolio and serves as liaison with cross-functional stakeholders and third party contractors to facilitate change management and issue resolution. May provide direction to junior staff to meet the expectations of this function.
- Perform Quality Assurance activities associated with new external product development, Innovative Lifecycle Management (ILM), or commercial projects ensuring accuracy and integrity of all data submitted to applicable regulatory bodies.
- For contractor manufactured products, serves as the Quality liaison between vendors, private label customers, and Upsher-Smith maintaining effective communication systems for quality expectations and compliance.
- Provide Quality guidance and expertise to facilitate product changes and issue resolution.
- Provide support to the Research & Development and Operations groups to promote continuity of product life-cycle management.
- Review and approve product related documents including, but not limited to, material specifications, finished product specifications, master batch records, change control documents, investigations, deviations, regulatory submissions, stability protocols, and process validations.
- Contributes to the compilation, review, approval, and reporting of Annual Product Reports.
- Performs quality audits of batch records to support finished product release for
- designated product during new product development.
- Represents company interests through review of contractor records for release of
- purchased product.
- Stays abreast of national and international industry and regulatory trends relating to
- quality; ensures that USL and contract manufacturer systems are administered in compliance with those policies and regulations providing subject matter expertise.
- Review and provides input to department operational procedures and practices
- pertaining to compliance with corporate standards, quality systems, SOPs and cGMPs.
- Initiate, review, and manage Supplier Corrective Action Requests and Supplier Notifications, when required.
- Participate in the Supplier Performance Monitoring program. Specifically, provide metrics and input for contract manufacturer scorecards to the External Quality Management group.
- Provide customer complaint notifications to contract manufacturers. Review and approve contract manufacturer complaint investigations.
- Participate in ILM or special projects as assigned by Quality Management.
- Work directly with partners/contractors to update or revise Quality Agreements, as necessary.
Requirements:
Bachelors Degree and 6 years’ experience required in a GMP-related industry (Pharmaceutical or Medical Device) with a minimum of 2 years of experience in Quality Assurance or Analytical Services/Quality Control. Broad working knowledge of Quality Systems and regulatory compliance programs required.
Compensation Range:
$91,719.00 - $137,579.00
Upsher-Smith Laboratories, LLC is committed to providing equal employment opportunity to all applicants and employees according to all applicable equal opportunity and affirmative action laws, directives and regulations of federal, state and local governing bodies and agencies. In keeping with this commitment, Upsher-Smith Laboratories, LLC will recruit, hire, train and promote persons in all job titles, without regard to race, color, creed, religion, sex (including factors related to pregnancy or child birth), national origin, age, marital status, familial status, disability, sexual orientation, gender identity status with regard to public assistance, employment status, local human rights commission activity, status as a protected veteran, genetic information, atypical hereditary cellular or blood trait, or any other protected category.
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