Quality Engineer at Leiters Inc

Inverness, Colorado, United States -

Full Time

Start Date

Immediate

Expiry Date

29 Dec, 25

Salary

0.0

Posted On

30 Sep, 25

Experience

2 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Quality Control, cGMP Requirements, Attention To Detail, Communication, Problem Solving, Collaboration, Documentation Skills, Regulatory Compliance, Change Control, Internal Audits, Investigation, Data Analysis, Process Improvement, Quality Systems, Manufacturing Processes, Compounding Techniques

Industry

Pharmaceutical Manufacturing

Description

Quality Engineer 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! Essential Functions: This description is intended to be illustrative of the major duties performed by the employee assigned to this position. * 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. Supervisory Responsibilities: * N/A Experience and Necessary Competencies: * Bachelor’s degree in relevant field or equivalent experience required. * 3+ years of quality experience required, preferably in a regulated industry. * Knowledge and experience of compounding techniques and controlled environments is preferred. * Knowledge of appropriate materials and conditions is preferred * 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 * Understanding of 503B regulatory requirements, cGMP standards, and USP guidelines is a plus! * Proficient written, verbal and oral English communication skills are required. * Proficiency with Microsoft 365 tools including Outlook, Microsoft, and Excel. Physical Requirements: * Ability to stand or sit for extended periods of time. * Ability to lift, push and pull up to 50 pounds periodically. Benefits: * 100% employer paid medical plan. * Dental & Vision insurance options including FSA & HSA * 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    Timeline: We will be accepting applications on an ongoing basis until position is filled.  We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity or expression, pregnancy, age, national origin, disability status, genetic information, protected veteran status, or any other characteristic protected by law. *Please note that we do not work with third-party recruiters or agencies for this position. If you are a qualified candidate and wish to apply for this job, please do so directly through our official application process. We appreciate your understanding and cooperation in this matter.

Responsibilities

The Quality Engineer leads investigations for quality events and assists with internal audits and regulatory inspections. They provide quality guidance and ensure compliance with quality systems and regulatory requirements.