- Expired: over a month ago. Applications are no longer accepted.
This position reports to the Manager of Quality Assurance. The Quality Engineer performs inspections and investigates quality events that occurred from cGMP activities. Assists in developing quality control policies and evaluates production limitations. The candidate should have a good understanding of cGMP requirements. The position requires an individual who works independently and in a team environment, experienced in cGMP requirements, quality control, attention to detail, strong writing skills and excellent communication with other functional areas and sites.
Essential Functions of Quality Engineer
Responsible for quality investigations and supporting activities including:
- Lead Investigations into Quality Events -Deviations, Complaints and Out of Specifications (OOS)
- Implementing methods to inspect, test and evaluate the reliability of the manufacturing processes, products, and product equipment
- Making sure processes adhere to quality standards
- Preparing investigation reports by collecting, analyzing, and summarizing data
- Working in accordance with defined deadlines for delivery of final reports
- Working closely with all areas: Quality, Production, Facilities, Technical Services, Supply Chain, and any other areas of need
- Provide quality guidance, expertise, and services to ensure decisions for processes, data and product are quality driven, compliant to batch records, operating procedures, and regulatory requirements.
- Provide oversight of process areas and documentation, including review of process-related documentation (e.g., production, maintenance, and lab data).
- Engage in cross-functional team discussions for issue resolution, process improvements and/or triage and initiate event records.
- Provide quality guidance and service to quality control, R&D, manufacturing engineering, production, procurement, and other departments.
- May provide, develop, implement, and evaluate tools and equipment for quality assurance and for product/process improvement and conformance.
- Complete quality department assignments with clearly defined objectives.
- Partner with peers to ensure alignment on issue resolution, decisions for processes, and compliance to batch records.
- May be required to create, revise, author documents, deviation records and maintenance records or perform trending activities.
- Expected to solve problems of limited scope and complexity, seeks management guidance as required.
- Work with a team to ensure that the systems involved in a 503B outsourcing facility are in a state of control
- Other duties as assigned to ensure appropriate quality practices
Experience & Necessary Skills of Quality Engineer
- Knowledge and experience with the Pharmacy CO Code of Regulations, CO Board of Pharmacies, and US FDA cGMPs, preferably in a commercial compounding outsource facility
- Knowledge and experience of compounding techniques, controlled environments, and compounding facilities
- Knowledge of appropriate materials and conditions
- Able to identify potential adverse issues
- Excellent organization and documentation skills
- BS or BA degree (in a scientific discipline desired);
- Knowledge and experience in a cGMP environment in manufacturing/laboratories
Benefits of Quality Engineer
- Health insurance
- Dental Insurance
- Vision Insurance
- Flexible Spending Account, Health Savings Account, Disability Insurance, Life Insurance, PTO, Employee Assistance Program
- 401K Matching
- Referral program: $1,000 with no limit
Our vision is to make the world a healthier place to live, and that starts with you! We believe everyone can be an impact player. Join Leiters and discover a career, not just a job. Our culture is centered around talent development where employees are given opportunities of growth to make a difference in our company as well as the world. Join Leiters and grow with us as we enter this stage of expansion.
Our foundation at Leiters is built on 5 core values:
Hold yourself and others to the highest standard. Always do the right thing, even when no one is looking.
Be an impact player. Focus on great results rather than progress. Have a bias for action and consistently demand strong performance.
Care intensely for our mission, vision, and patient care. Inspire others in a quest for excellence
Be creative and innovative in solving problems and delivering the highest quality products with exceptional customer service. Do not tolerate the status quo.
Helping and supporting one another. Holding yourself and others accountable to the Company’s mission, vision, values and goals. Working together with our customers to meet mutual goals.
Leiters is a trusted FDA-registered 503B outsourcing provider of high-quality hospital and ophthalmology compounded sterile preparations. We are committed to providing healthcare professionals and their patients with critically needed outsourced medications. Our team of experts in sterile pharmaceutical manufacturing, repackaging, and compounding provide a sophisticated understanding of what it takes to elevate quality and consistency of supply in pharmaceutical outsourcing. Leiters combines a highly experienced team, with robust automated processes, in a state-of-the-art outsourcing facility, to ensure delivery of the highest quality medicines. All sterile preparations are produced under the Human Drug Outsourcing Facilities under 503B of the FD&C Act (503B Guidance) and follow Current Good Manufacturing Practices (cGMP). Leiters. Where Quality Means Something.
Celebrate, Foster, and Empower- Diversity, Equity, and Inclusion
Leiters mission to provide better medicine to more people fosters the opportunity to celebrate diversity and empower all members of the organization to be inclusive. Diversity, equity, and inclusion (DE&I) is an integral to our culture and fuels our growth. At Leiters, we are committed to building a team with diversity of thought, experience, background, skills, and culture. We value the unique qualities and skillsets each of our team members bring to our company. The more inclusive we are, the better we perform. Creating and sustaining diversity, equity and inclusion is imperative as we build for success.
ManufacturingView all jobs at Leiters Inc
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