Quality Director – East Texas Area
Kelly Scientific Resources is currently seeking a Quality & Regulatory Director for one of our top manufacturing dietary supplement/pharmaceutical client located in East Texas area. This position is located 1 ½ hour East of Dallas, TX.
As a Quality & Regulatory Director you will be responsible for overseeing all aspects of the organization’s quality function. Responsible for planning and directing quality policies, programs, and initiatives to continuously improve the quality of organizational processes, products and services.
Additional Job Responsibilities:
- Direct all Quality Control/Quality Assurance department activities and programs
- Lead customer audits and regulatory agency inspections
- Direct document control, and product conformance reporting programs (CAPA, CAR, etc.)
- Review product specifications to ensure customer needs are met and that they can reasonably be met with available manufacturing resources.
- Review operations and confer with technical or administrative staff to resolve production or processing problems.
- Review processing schedules and production orders to make decisions concerning staffing requirements, work procedures, and duty assignments, considering budgetary limitations and time constraints.
- Hire, train, motivate, evaluate, and discharge staff, and resolve personnel grievances.
- Prepare written standards and specifications for processes, equipment, products, and tests.
- Compile and analyze inspection and test information to determine process or equipment operating efficiency and to diagnose malfunctions or errors.
- Develop and/or evaluate material tracking and quality systems.
- Customer and internal product testing.
- Document Control (Maintain Specifications, Procedures, Formulas)
- Maintain supplier auditing programs and qualify new suppliers and ingredients.
- Update and maintain written quality control programs.
- Develop and maintain specifications for finished goods, raw materials, and components.
- Direct supervision of quality control manager and laboratory personnel. Lead quality control initiatives and provide guidance and training to quality department and production employees (direct and indirect reports).
- BS in Applied Science or Technical Field
- 5+ years previous QA experience in cGMP environment
- 3+ years minimum as supervisor or manager in pharmaceutical (CFR211), dietary supplement (CFR111), or food (CFR110)
- Candidates with prior experience as an FDA investigator is preferred though not required.
- Bilingual (English/Spanish), preferred.
- Excellent problem solving skills.
- Computer literate: Microsoft Office (Word, Excel, Outlook).
- Knowledge or experience in operating production and warehouse equipment
- GMP training experience
With Kelly, you’ll have access to some of the world’s highest-regarded scientific organizations—providing you with opportunities to work on today’s most challenging, research-intensive, and relevant projects. Our connections can lead you to innovative scientific pursuits you’ll be proud to help advance. We work with 95 of the Fortune 100™ companies, and found opportunities for more than 11,000 scientific professionals last year.
You pursued a career in science to fuel your quest for knowledge and your desire to make the world a better place. Let Kelly fuel your career—connect with us today.
As a workforce advocate for over 70 years, we are proud to directly employ nearly 500,000 people around the world and have a role in connecting thousands more with work through our global network of talent suppliers and partners. Revenue in 2016 was $5.3 billion. Visit kellyservices.com and connect with us on Facebook, LinkedIn and Twitter.
Kelly Services is an equal opportunity employer including, but not limited to, Minorities, Females, Individuals with Disabilities, Protected Veterans, Sexual Orientation, Gender Identity and is committed to employing a diverse workforce. Equal Employment Opportunity is The Law.