3rd Shift -Supervisor, Manufacturing Quality Assurance

Job Overview:

Responsibilities:

• Ensure Quality systems are compliant with corporate and site procedures as well as industry standards such as but not limited to Annual Product reviews, Complaints, Investigations, and root cause analysis, Corrective and Preventive Actions, and Training.
• Supervise the Quality Assurance Associates.
• Function as the Quality department liaison and subject matter expert to other department representatives, customers, and regulatory representatives.
• Maintain positive employee relations, including problem resolution process.
• Ensure the adherence to the standards of quality ruled by current cGMPs and the Company's Quality Policies and site Standard Operating Procedures.
• Author/review and ensure currency of SOPs related to the area of responsibility.
• Propose, implement, and enforce quality improvements.
• Perform other duties as assigned.

Qualifications: 

• BS in Science or related degree, or at least 7-10 years of supervisory/management experience within the pharmaceutical or medical device industry with emphasis in Quality areas preferred.
• Prior supervisory/management experience preferred.
• Experience in successfully managing complex technical issues using structured analysis and methodology and articulating clear and concise direction to other operations staff. 
• Strong experience with project and people management.
• Able to administer personnel performance evaluations.
• Demonstrate the ability to write and understand technical information and produce detailed reports.
• Demonstrates good leadership skills and the ability to establish and maintain good working relationships with other departments, including vendors, colleagues, and subordinates.
• Demonstrates the appropriate technical knowledge necessary to make sound decisions on development issues with minimal supervision.
• Demonstrates the appropriate technical knowledge necessary to make sound decisions on development issues with minimal supervision.
• Must be able to comprehend and follow all applicable SOPs.
• Demonstrate knowledge and experience with electronic Quality Management Systems such as MasterControl and Trackwise.
• Demonstrate understanding/ability to acquire the appropriate knowledge from resources on the current federal, local, and international regulations regarding the production, testing, and release of drug substances and products.
• Good understanding of cGMPs, industry, and regulatory standards and guidelines.
• Demonstrate familiarity with Microsoft programs like Word, Excel, PowerPoint, Project, Teams, Outlook, etc.
• Demonstrate the ability to portray the appropriate level of integrity and professionalism.
• Demonstrate the ability to communicate effectively with management, staff, regulators, and client representatives in written and verbal formats.
• Demonstrate the ability to complete tasks accurately and according to established and shifting timelines.
• Demonstrate the ability to make quality scheduling, resource allocation, and priorities decisions.
• Energetic, execution-focused, self-motivated, and organized individual who is accustomed to working in a deadline-focused, high-pressure entrepreneurial environment.
• Results-oriented and efficient.
• Creative and open-minded who fosters an environment in which sharing of ideas is encouraged.
• Demonstrate the ability to work closely with a diverse customer and employee base (internally and externally).
• Demonstrate the ability to work well in a cross-functional team environment.
• Must communicate fluently in English and have legible handwriting.

Physical Demands: 

• Ability to travel between and within facilities to visit staff, operations, and projects, as needed.
• Ability to sit, stand, climb stairs, and climb ladders to mezzanines (when necessary).
• Ability to lift up to 40 pounds on occasion.
• Ability to use PPE (safety shoes, goggles, respirators, gloves, etc. when necessary). 110000.00 To 120000.00 (USD) Annually