Smithnephew
Senior Quality Control Manager (Fort Worth, TX)
Company
Smithnephew
Role
Senior Quality Control Manager (Fort Worth, TX)
Location
United States of America
Job type
Full time
Posted
Yesterday
Salary
Job description
Life. Unlimited. At Smith+Nephew we design and manufacture technology that takes the limits off living.
As a Senior Quality Control Manager, you will play a critical leadership role within our Drug Product Operations, ensuring the highest standards of quality, compliance and scientific excellence. This is an opportunity to lead a high performing QC team, influence key quality decisions and make a meaningful impact on products that improve patients’ lives every day.
What will you be doing?
Leading and overseeing day to day Quality Control laboratory operations to ensure timely and accurate testing of raw materials, in process samples, finished products and stability samples
Acting as the primary decision maker for QC investigations including OOS, OOT and atypical results, applying robust root cause analysis to drive sustainable corrective actions
Providing technical leadership and subject matter expertise across semi solid, liquid, ointment and cream formulations and analytical testing methods
Supporting aseptic manufacturing operations, environmental monitoring programs and sterility assurance activities in close partnership with Manufacturing and Quality Assurance
Developing, mentoring and coaching QC analysts and supervisors, building strong technical capability and fostering a culture of accountability and continuous improvement
Ensuring all QC documentation, policies and laboratory systems meet GMP and GDP requirements, while leading audits and supporting regulatory inspections
What will you need to be successful?
A Bachelor’s degree in Chemistry, Microbiology, Pharmaceutical Sciences or a related scientific discipline
Extensive Quality Control experience within pharmaceutical drug product manufacturing, with strong exposure to semi solids, liquids, ointments and creams
Proven leadership experience managing and developing QC teams in a GMP regulated environment
Deep working knowledge of FDA 21 CFR Parts 210 and 211, with hands on experience leading laboratory investigations and root cause analysis
Experience supporting aseptic manufacturing operations and associated quality requirements
Strong communication skills with the ability to partner effectively across Manufacturing, Quality Assurance and other stakeholders
You. Unlimited.
We believe in creating the greatest good for society. Our strongest investments are in our people and the patients we serve.
Inclusion and Belonging- Committed to Welcoming, Celebrating and Thriving on Inclusion and Belonging, Learn more about Employee Inclusion Groups on our website (https://www.smith-nephew.com/).
Your Future: 401k Matching Program, 401k Plus Program, Discounted Stock Purchase Plan, Tuition Reimbursement
Work/Life Balance: Flexible Personal/Vacation Time Off, Paid Holidays, Flex Holidays, Paid Community Service Day
Your Wellbeing: Medical, Dental, Vision, Health Savings Account (Employer Contribution of $500+ annually), Employee Assistance Program, Parental Leave, Fertility and Adoption Assistance Program
Flexibility: Hybrid Work Model (For most professional roles)
Training: Hands-On, Team-Customized, Mentorship
Extra Perks: Discounts on fitness clubs, travel and more!
Smith+Nephew provides equal employment opportunities to applicants and employees without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability.
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