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 benefit package, including: Medical, Dental, and Vision Insurance Company
Paid Short-Term Disability, Long-Term Disability and AD&D Annual Anniversary Cash Award On-Site Nurse Company Paid Employee Assistance Plan 401k with match Annual Anniversary Cash Award POSITION SUMMARY The QA Engineer - Validation job function is responsible for performing quality assurance tasks and activities with minimal guidance and supervision.
The emphasis for this position is on coordinating and supporting validation activities for the design, startup on equipment, and process validations for new and ongoing operations of the Ortec Piedmont facility. Technical duties include authoring and executing validation documents, defining validation strategy, reviewing and analyzing data, and incorporating continuous improvement into validation programs.
This individual will provide oversight of validation activities, lead the development and approval of validation documentation, risk backssments, work with project teams to determine which elements should be validated, and conduct impact backssments of proposed changes to systems. The QA Engineer role will also help support the implementation, coordination, and maintenance of Ortec's Quality Systems. ESSENTIAL FUNCTIONS Write, execute, summarize and lead validation projects in the following areas: facility design and validation (utility systems, environmental chambers, HVAC, for example) production and processing equipment process validations cleaning validations plant automation (PLC, SCADA and comparable systems) computer system validation.
Develop project timelines, maintain team schedules, and communicate progress to peers and senior management. Review and analyze test data. Obtain client approval for contracted validation projects and reports. Review and administer validation activities originating from process and equipment change control. As a subject matter expert, help develop responses to compliance audit findings (internal, client, and FDA).
Participate as member of audit support teams, representing validation programs, policies, and projects. Chair and coordinate FMEA teams, author FMEA reports and manage risk backssment activities for change control. Coordinate with Production, Quality, Maintenance, and other departments as needed to manage projects, implement production capacity increases, and validate process improvements. Define and implement global equipment and instrument maintenance and calibration program. Helps provide technical assistance to carry out problem analysis/complaint investigation where necessary, e.
g. quality events investigation and CAPAs Support audit readiness with understanding of FDA and ISO regulations and requirements. Maintain a safe, clean, and organized environment (5S) for all QA areas. Follow all SOPs and Safety Guidelines to ensure compliance with a c GMP environment and Safety Practices Any additional functions as assigned by the QA Manager Sustain, and uphold Ortec's Guiding Principles in all day-to-day actions EDUCATION Bachelor's degree in Business, English, or Science related field with 2+ years related experience Bachelor's degree in Business, English, or Science related field with 5 years related experience, preferred EXPERIENCE Preferred: Minimum 2+ years' experience in regulated manufacturing environment - chemical, medical or medical device with quality assurance responsibilities, specifically in technical writing Experience with regulatory inspections and writing validation protocols SKILLS & ABILITIES Demonstrated knowledge of validation principles Demonstrate knowledge of c GMP's including sections 211 and 820 Strong analytical and problem solving skills Proficient computer skills: Microsoft Outlook, Excel and Word.
Experience with Minitab desirable 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 This job posting is not all inclusive, please see job description for details. Applicants may be subject to pre-employment screening which may include drug screening, reference checks, employment verifications, and background screenings.
Ortec is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, interactionual orientation, gender identity, national origin, veteran or disability status.
