Position Description

As Quality Control (QC) Manager, the incumbent will be responsible for successfully providing technical and analytical leadership to the QC function including microbiology labs. The person will be responsible for overseeing the lab instrumentation qualification and operation as well as coordinating the analytical test method transfers and validations. The individual will be responsible for the execution and administration of the GXP Quality System pertaining to QC as well as for managing lab investigations/deviations. The individual should be willing to participate hands-on in writing procedures as well as in conducting testing. Experience with HPLC/UPLC and in working in a GMP/regulated laboratory environment is preferred.

Essential Duties & Responsibilities

• Maintaining QC function in compliance with applicable GXP regulations.
• Delivering QC operational performance and providing a timely assessment of any gaps in labs capability.
• Oversee the qualification and operating procedure creation for various lab equipment
• Provide support for maintaining training files for employees to ensure compliance with applicable regulations
• Ensure that all quality trends are evaluated, that root causes are identified, and corrective actions are implemented.
• Ensure that the receipt, control, sampling, inspections, testing, and disposition status for all raw materials and associated components upon transfer from distribution or other authority comply with regulatory requirements
• Participate in analytical method development for HPLC/UPLC based methods
• Participate in the customer complaints reviews, change controls assessments, deviation investigations, and resulting CAPAs
• Oversee the finished product retain system
• Escalate properly to Senior Management of potential or real situations that require management addressing.
• Stay abreast of evolving regulatory compliance practices related to GMP and GLP systems.
• Other duties as assigned

Regularly interacts with other key functions, senior leadership and external clients.

Establish and maintain an environment that stresses and encourages teamwork.

Qualification & Experience

• Bachelor’s degree in Science or Engineering; graduate degree preferred
• Strong problem-solving skills & excellent oral and written communication skills
• Strong ability to motivate QC team
• Experience in either the pharmaceutical industry, or lab operations environment
• Preferred Proficiencies: MS Visio, MS Project, MS Excel, MS Power Point, MS Word, or similar software platforms

Job Type: Full-time

Benefits:

• 401(k)
• 401(k) matching
• Dental insurance
• Health insurance
• Life insurance
• Paid time off
• Vision insurance

Schedule:

• 8 hour shift
• Monday to Friday

Ability to Relocate:

• Menomonie, WI: Relocate before starting work (Required)

Work Location: In person