Sr. Product Quality Specialist

2 months ago

Maple Grove, Minnesota, United States Upsher-Smith Laboratories, LLC Full time

Upsher-Smith Laboratories, LLC is seeking a Sr. Product Quality Specialist to share time between Plymouth, MN, and Maple Grove, MN, to be responsible for providing Quality support to the Upsher pharmaceutical product portfolio, inclusive of products in development through the lifecycle of discontinuation. In addition, this position will also represent QA on relevant project teams and provide general quality guidance to meet project milestones. Furthermore, the Sr. Product Quality Specialist will act as the Quality subject matter expert based upon product portfolio and will serve as a liaison with cross-functional stakeholders and third-party contractors to facilitate change management and issue resolution. Finally, this position will utilize quality and risk management processes/tools to ensure compliant and efficient processes. The specific duties and responsibilities of this position include:

Perform Quality Assurance activities associated with new product development, CCMS or commercial projects to ensure accuracy and integrity of all data submitted to applicable regulatory bodies.

Stay abreast of national and international industry and regulatory trends relating to quality; ensures that Upsher-Smith systems are administered in compliance with those policies and regulations providing subject matter expertise.

For contract development project teams, serve as the Quality liaison between vendors, and Upsher-Smith maintaining effective communication systems for quality expectations and

compliance.

Responsible for review regulatory submission documents.

Support internal, customer, and regulatory inspections.

Review and approve equipment qualification documents (i.e. IQ, OQ, PQ, URS/FS optimization, maintenance and calibration, etc.).

Collaborate to ensure facilities/ utilities meets industry standards.

Use process knowledge and root cause determination techniques to troubleshoot and identify root cause, failure analysis, and determination of appropriate corrective/preventative

actions.

Openly collaborate with Operations, TS, QC, Engineering, etc. in daily compliance functions; provide Quality guidance and expertise to facilitate product changes and issue resolution.

Utilize risk analysis to assess product impact and determine corrective/ preventative actions.

Utilize strong technical writing skills to ensure clear, concise investigation summaries.

Provide support to the Technical Service and Operations groups to promote continuity of product lifecycle management.

Review and approve product related documents including, but not limited to, material specifications, finished product specifications, master batch records, change control documents,

investigations and deviations.

Responsible for executed batch record review, batch disposition, customer complaints, and various GMP records (i.e. SOPs, deviations, etc.).

Contribute to the compilation, review, approval, and reporting of Annual Product Quality Reports.

Perform quality audits of batch records to support finished product release for designated product during new product development.

Independently identify compliance gaps or inefficient processes. Develop or optimize current business processes.

Review and provide input to department operational procedures and practices pertaining to compliance with corporate standards, quality systems, SOPs and camp.

Educate junior staff members and cross functional departments on new and changing regulation/requirements.

The position requires a bachelor's degree in biology, Chemistry, Biological Sciences, or a related Physical Science, or a foreign equivalent degree. We also require 5 years of progressively responsible experience in a GMP-related industry (Pharmaceutical or Medical Device). The experience must include: 4 years of Change Controls and CAPAs; 3 years of performing investigations, risk assessment and root cause analysis; 2 years of project team experience; and 2 years of Quality Systems and regulatory compliance programs. Experience can be gained concurrently. My partially telecommute from home but must reside within normal commuting distance of the Twin Cities metropolitan area as the position will be required to work onsite in our Plymouth and Maple Grove, MN manufacturing facilities. Minimal travel (0-5%) within the US. Please apply online at or send resume to Ramin Rigi, Upsher-Smith Laboratories, LLC, 6701 Evenstad Drive, Maple Grove, MN 55369 or Ramin.-

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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