Quality Engineer

Leiters Inc•Inverness, CO

About The Position

This position reports to the Quality Systems Manager. The Quality Engineer performs inspections and investigates deviations from current quality practices. 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, and excellent communication with other functional areas and sites. Why Join Leiters Health? Are you passionate about making a real impact in the pharmaceutical industry? Do you thrive in a collaborative, innovative environment where your skills and ideas are valued? Look no further – Leiters Health is seeking talented individuals like you to join our dynamic team! At Leiters Health, we're not just another pharmaceutical company – we're pioneers in the field, dedicated to delivering high-quality compounded sterile products and outsourced solutions to healthcare providers nationwide. Our commitment to excellence and patient safety is at the core of everything we do. Innovative Culture: Be part of a forward-thinking company that encourages creativity, welcomes fresh ideas, and fosters an environment of continuous improvement. Meaningful Work: Contribute to a purpose-driven organization dedicated to providing critical medications and healthcare solutions that positively impact patients' lives. Professional Development: Access ongoing training, mentorship, and growth opportunities to expand your skills and advance your career within a rapidly growing industry. Cutting-Edge Technology: Work with state-of-the-art facilities and advanced technologies, staying ahead of the curve in pharmaceutical manufacturing. Collaborative Environment: Join a team of passionate individuals who are dedicated to teamwork, support, and mutual success, fostering a culture of inclusivity and collaboration. Who We're Looking For: We're seeking enthusiastic individuals who are driven, adaptable, and passionate about contributing to a mission-driven organization. Whether you're an experienced professional or just starting your career, Leiters Health provides an environment where your skills and talents will be recognized and appreciated. Sound like you? Apply today!

Requirements

Bachelor’s degree in relevant field or equivalent experience required.
3+ years of quality experience required, preferably in a regulated industry.
Ability to identify potential adverse issues
Excellent organization and documentation skills
Demonstrated ability to solve problems of limited scope and complexity, seeks management guidance as required.
Collaborative spirit, able to work with a team to ensure that the systems involved in a 503B outsourcing facility are in a state of control
Proficient written, verbal and oral English communication skills are required.
Proficiency with Microsoft 365 tools including Outlook, Microsoft, and Excel.
Ability to stand or sit for extended periods of time.
Ability to lift, push and pull up to 50 pounds periodically.

Nice To Haves

Knowledge and experience of compounding techniques and controlled environments is preferred.
Knowledge of appropriate materials and conditions is preferred
Understanding of 503B regulatory requirements, cGMP standards, and USP guidelines is a plus!

Responsibilities

Lead investigations for quality events, deviations and complaints
Review and assist with implementation of changes through the change control process.
Lead and assist with internal audits through the internal audit program.
Assist with regulatory inspections and serve as Subject Matter Expert (SME) related to quality systems including deviations, CAPAs, change controls, etc.
Implementing methods to inspect, test and evaluate the reliability of the manufacturing processes, products, and product equipment
Prepare and deliver on time investigation reports by collecting, analyzing, and summarizing data
Serve as Subject Matter Expert (SME) and ensure compliance with integrity of BMRAM system staying current with quality reviews and improving timeliness of equipment calibration.
Provide quality guidance, expertise, and services in collaboration with all departments to ensure decisions for processes, data and product are quality driven, compliant to batch records, operating procedures, and regulatory requirements.
Engage in cross-functional team discussions for issue resolution, process improvements and/or triage and initiate event records.
Partner with peers to ensure alignment on issue resolution, decisions for processes, and compliance to batch records.
Create, revise, and author documents and deviation records.
Perform trending reports.
Assist with 503B regulatory activities such as state regulatory reporting, DEA record keeping and diversion investigations.
Other duties as assigned.

Benefits

Smart healthcare coverage options that rewards wellness (and puts money back in your pocket!)
Flexible Spending & Health Savings Accounts (FSA & HSA) available
Dental & Vision insurance
Employer Paid Life Insurance & Employee Assistance Program
Short Term & Long-Term Disability Insurance
Up to 4% 401K Matching (100% vested on day one!)
Generous Paid Time Off Options – vacation, sick, paid leave and holidays!
$5,250 Annual Tuition Reimbursement after 6 months
$1,000 Referral Bonus Program with no limit
Eligible for annual bonus program