Quality Assurance Manager na None

Quality Assurance Manager impacts various responsibilities from the operation and project management needs to customer support and management.  The manager will oversee a group of QA professionals from all experience levels and will be the primary point of contact for managing projects.  The manager will use SKPT's Quality Systems (managed within Master Control, an electronic document management system) to ensure timely progressions and accurate completion of documents. This position includes the management of a team of QA specialists and analysts to support production lines and customer expectations.  May manage experienced professionals who exercise latitude and independence in their assignments.  

Duties and Responsibilities: 

• Ensuring adequate QA resources are provided for the cross-functional internal team meetings and customer teleconferences.
• Responsible for managing the quality aspects of the start-up of production lines through the release of final products manager will align customer needs and the Company's completion projections for the lots manufactured.
• Taking an active role in providing, as needed, guidance within the approved systems and procedures related to GMP production and release of products. Some of this guidance may be required outside of the typical working schedule (off-shift).
• Taking an active role in planning and, when needed, executing action items related to the support of production and product release, including document control and production record review activities.
• Managing the release of products to support subsequent production and release of products to customers within the approved systems and procedures. Managing change controls in support of production and release activities.
• Review and/or conduct of investigations for deviations in production and testing.
• Manager will review input for Quality Technical Agreements (QTA). The manager will ensure their team can access the QTA and closely follow the approved agreements.
• Ensuring process validation and qualification requirements are established in approved protocols, and results of the validation and qualifications are accurately presented in approved reports.
• Responsible for managing facility audits of the respective manufacturing facilities of responsibility at the start of each campaign and periodically while long-running campaigns are active.
• The manager is expected to monitor the progress of the quality systems and work with system coordinators to drive KPI improvement.
• QA manager is responsible for managing all quality aspects related to the product(s) assigned.
• Direct management of 2-5 QA professionals in support of GMP manufacturing.
• Work with other functional management to proactively look for continuous improvement in the quality organization and assist in improving manufacturing operations.
• Involvement in customer and regulatory audits as the QA representative subject matter expert for the product(s) of responsibility.
• Closely monitor KPI (key performance indicators) for products under your responsibility and create tools, training, changes, procedure, etc., to create an environment of continuous improvement.

EDUCATION AND EXPERIENCE

• Bachelor’s degree in appropriate science required.
• 7 years Quality Assurance technical experience required.
• 4+ years management experience required.

COMPETENCIES/SKILLS

• Strong attention to detail.
• Ability to work in a fast paced, team-oriented environment.
• Ability to act with a sense of urgency, while maintaining accuracy and data integrity.
• Strong team building, decision-making, and people management skills.

CERTIFICATIONS and LICENSES

• Not Applicable

This job description does not constitute a contract of employment or otherwise limit employment-at-will rights at any time.