Quality Supervisor - Filling (weekend AM)

The role

The Quality Supervisor provides oversight and decision-making to ensure finished products meet specifications. This person supervises QALO personnel and supports Environmental Monitoring and Manufacturing to ensure compliance with regulatory regulations and company SOPs.

What you will do

• Perform all primary responsibilities of EM and QALO personnel
• Grow, manage, develop and empower personnel including hiring and evaluation
• Provide rapid, quality-first decision-making in collaboration with cross-functional teams
• Ensure training and compliance of QALO associates and Quality Technicians
• Author and approve investigation/deviation reports
• Lead daily QALO and environmental monitoring activities
• Ensure tasks are completed to meet Quality and site metrics
• Author, revise, and review SOPs, batch records, and other documentation
• Ensure compliance with federal, state, local and company-specific regulations
• Participate in and lead process/product improvement projects and validations

Required qualifications

• Bachelor’s degree and 2 years of Pharmaceutical Quality/Manufacturing or other GXP regulated industry experience, or Associate’s degree with at least 3 years of Pharmaceutical Quality/Manufacturing or
• Minimum of 2 years of leadership experience
• Working knowledge of FDA CFR 210,211 and other applicable regulations, and Good Documentation Practices (GDP)
• Knowledge of aseptic manufacturing processes
• Good interpersonal/communication/influencing/negation skills
• Computer proficiency in Microsoft Word, Excel, and Outlook and the ability to use enterprise software
• Strong technical, analytical, and problem-solving skills
• Must wear appropriate PPE as required for various manufacturing areas
• Must be able to gown qualify for Grade C/D areas
• Duties may require overtime work, including off-shift hours and Holidays as required
• Use of hands and fingers to manipulate office equipment is required

Nice to have

• Preferred science discipline
• Experience with environmental monitoring
• Familiarity with isolator filling machines

Benefits

• Medical & Dental Coverage
• Flexible Spending Accounts
• Life and AD&D Insurance
• Supplemental Life Insurance
• Spouse Life Insurance
• Child Life Insurance
• 401(k) Retirement Savings Plan with Company Match
• Time Off Program
• Paid Holidays
• Paid Time Off
• Paid Parental Leave
• Adoption Reimbursement Program

About the company

Simtra BioPharma Solutions (Simtra) is a world-class Contract Development Manufacturing Organization, partnering with pharmaceutical and biotech companies to bring their sterile injectable products to market.