QA Specialist - CAPA Coordinator
Ortec has been providing custom chemical solutions and personalized service since 1980. With three plants and over 300 employees, we can meet the production needs of our customers while maintaining a high level of personalized service. We are large enough to get the job done, yet small enough to care. Even as the company grows and develops new services, we never forget the values that made us who we are as a company.
We are a team. A family. A group of smart, talented, big-hearted individuals working together for the success of our customers and the growth of our communities.
AND WE HONOR OUR COMMITMENTS
What we do at Ortec is complicated at times. Why we do what we do is not complicated: We want to make a difference for our customers and our communities around us. How we do what we do is also not complicated: everything starts with Integrity.
WHY ORTEC? The foundation of Ortec is our talented, dedicated employees. Our commitment to delivering chemical manufacturing services with measurable quality has made us a trusted partner to some of the most familiar names in business. Our success is drawn from the experience, energy, and teamwork of our employees, who consistently deliver results by anticipating change and executing solutions with confidence and passion. At Ortec, you'll be working with the latest technologies and tools, not to mention some of the industry's best and brightest minds. From the top down, this type of commitment and energy is radiated throughout the company. The result is a growing, dynamic, and rewarding place to work a company where we work as many, and we win as one. You are a name, not a number!
We offer an excellent benefits package, including:
• Medical, Dental, and Vision Insurance
• Company Paid Short-Term Disability, Long-Term Disability & AD&D
• Annual Anniversary Cash Award
• Quarterly Perfect Attendance Bonus
• On-Site Nurse
• Company Paid Employee Assistance Plan
• 401k with match
Position Summary
The QA Specialist: CAPA Coordinator job function is responsible for performing quality assurance tasks and activities with minimal guidance and supervision. The emphasis for this position will be on administrative functions associated with Corrective and Preventive Actions (CAPA) and Root Cause Investigations. This individual will provide oversight of CAPA activities, as well as assist with document control, document archive activities, and data entry. The QA Specialist role will help support the implementation, coordination, and maintenance of Ortec’s Quality Systems.
Essential Functions
• Helps oversee the CAPA program, ensuring timely identification and resolution of nonconformances
• Support analysis of quality metrics to identify trends and drive continuous improvement initiatives
• Scan and archive quality system control records (raw material, production equipment cleaning, intermediate product and final product batch sheets with associated data)
• Review documents and forms according to good documentation practices (GDocP) for accuracy, clarity, and completeness; generate/revise documents as needed following change control process
• Supports special projects as assigned
• Support audit readiness with an understanding of FDA (21 CFR 210/211 and 21 CFR 820) and ISO (9001:2015 and 13485) regulations and requirements.
• Review and approve batch records as needed
• Issue final product Certificates of Analysis as needed
• Maintain a safe, clean, and organized environment (5S) for all QA areas.
• Follow all SOPs and Safety Guidelines to ensure compliance with a cGMP environment and Safety Practices
• Sustain and uphold Ortec’s Guiding Principles in all day-to-day actions
• Any additional functions as assigned by the QA Director
EDUCATION
• Bachelor’s degree in Business, English, or Science related field with 2+ years related experience, preferred.
Experience
• Preferred: Minimum 2+ years’ experience in regulated manufacturing environment - chemical, pharmaceutical or medical device with quality assurance responsibilities, specifically in technical writing
Skills & Abilities
• Proficient computer skills: Microsoft Outlook, Excel and Word.
• Excellent oral and written communication skills in English.
• Attention to details, ability to meet deadlines and work independently in fast-paced environment
• Ability to assertively interact with people at all levels of the organization
• Excellent technical writing skills
• Ability to think proactively
• Strong interpersonal skills, ability to be flexible and work well as a team player
Ortec is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sexual orientation, gender identity, national origin, veteran or disability status.
Chemical Manufacturing
Quality Assurance
Full-time