Senior Quality Assurance Specialist, Operations

Galderma • Fort Worth, TX

17h • Hybrid

About The Position

Galderma is the emerging pure-play dermatology category leader, present in approximately 90 countries. We deliver an innovative, science-based portfolio of premium flagship brands and services that span the full spectrum of the fast-growing dermatology market through Injectable Aesthetics, Dermatological Skincare and Therapeutic Dermatology. Since our foundation in 1981, we have dedicated our focus and passion to the human body's largest organ - the skin - meeting individual consumer and patient needs with superior outcomes in partnership with healthcare professionals. Because we understand that the skin, we are in shapes our lives, we are advancing dermatology for every skin story. We look for people who focus on getting results, embrace learning and bring a positive energy. They must combine initiative with a sense of teamwork and collaboration. Above all, they must be passionate about doing something meaningful for consumers, patients, and the healthcare professionals we serve every day. We aim to empower each employee and promote their personal growth while ensuring business needs are met now and into the future. Across our company, we embrace diversity and respect the dignity, privacy, and personal rights of every employee. At Galderma, we actively give our teams reasons to believe in our bold ambition to become the leading dermatology company in the world. With us, you have the ultimate opportunity to gain new and challenging work experiences and create an unparalleled, direct impact. Job Title: Senior Quality Assurance Specialist, Operation Location: Ft. Worth, TX / Dallas, TX (Hybrid) Job Description: The QA Specialist works independently to provide quality assurance oversight of any area assigned where the business is responsible for adhering to current Good Manufacturing Practices (cGMPs) including critical utilities, (e.g. Automation, equipment, HVAC, etc.), warehouse, distribution processes, inspection, labeling and packaging, batch disposition, new product introduction. Quality oversight responsibilities include ensuring adherence to SOPs and requirements, proper change control, corrective action and preventive action plans (CAPA)/Deviation management, impact assessments for changes to processes, risk management, and ensuring documentation and investigations meet all requirements.

Requirements

• Bachelor's degree required
• At least five to seven years of related experience in Quality Assurance within a regulated environment or transferrable industry experience
• Knowledge of applicable GXP regulations
• Knowledge of auditing techniques
• Working knowledge of applicable computer software
• Good organization and communication skills
• Ability to manage multiple tasks
• Good writing skills

Responsibilities

• Responsible for the quality release process for finished product distribution, including visual inspection of the finished product for the US market
• Manages temperature monitoring program for the distribution center, cold storage area and shipment of finished products.
• Works with manufacturing sites to resolve quality issues such as consumer complaints, shipping and/or product storage conditions
• Review and approve artwork and rework instructions to ensure cGMP requirements are met
• Participates in multifunctional project teams to support the introduction of new products and/or changes to current products to ensure compliance with Quality System requirements
• Participates in inspection readiness activities and significantly involved in inspections by regulatory agencies.
• Provides guidance and control directives regarding remediation activities required to continue business operations.
• Resolves critical issues within the area assigned and may escalate to senior management team based on the severity of the problem
• Works closely with others in the assigned area to recognize opportunities for improvement and drive change through the use of the monthly quality improvement meeting. May be asked to lead process improvement initiatives.
• May also attend, as a QA project team member to provide QA guidance and oversight to such improvements
• Acts as back up for other personnel within QA.
• Other duties may be assigned

Benefits

• You will be working for an organization that embraces diversity & inclusion and believe we will deliver better outcomes by reflecting the perspectives of our diverse customer base.
• You will also have access to a range of company benefits, including a competitive wage with shift differential, annual bonus opportunities and career advancement and cross-training.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level