Quality Supervisor - Filling (weekend AM)

The role

The Quality Supervisor provides support to Quality Operations and Manufacturing to ensure finished products meet specifications. This person supervises QALO personnel and drives quality operations on the production floor.

What you will do

• Perform all primary responsibilities of QALO personnel
• Grow, manage, develop and empower QALO 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 ongoing daily QALO 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 3 years, or no degree with 5 years
• Minimum of 2 years of leadership experience
• Working knowledge of FDA CFR 210, 211 and other applicable regulations
• Good Documentation Practices (GDP)
• Knowledge of aseptic manufacturing processes
• Good interpersonal, communication, influencing and negation skills
• Computer proficiency in Microsoft Word, Excel, and Outlook
• Ability to use enterprise software such as D365, Blue Mountain, Veeva, etc.
• 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
• Use of hands and fingers to manipulate office equipment

Nice to have

• science discipline

Benefits

• Day One 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

About the company

Simtra BioPharma Solutions is a Contract Development Manufacturing Organization that partners with pharmaceutical and biotech companies to bring sterile injectable products to market.