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Leiters Health · 9 hours ago

Quality Engineer

Englewood, CO, US

Full-time

Onsite

Mid Level

$74K/yr - $92K/yr

3+ years exp

Leiters Health is a pioneering pharmaceutical company dedicated to delivering high-quality compounded sterile products and outsourced solutions to healthcare providers. The Quality Engineer role involves performing inspections, investigating deviations from quality practices, and assisting in the development of quality control policies to ensure compliance with cGMP requirements.

Health CarePharmaceutical

H1B Sponsor Likely

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

Qualification

CGMP requirementsQuality controlRegulatory inspectionsCompounding techniquesMicrosoft 365Problem-solvingAttention to detailCommunication skillsCollaborative spiritOrganizational skills

Required

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

Good understanding of cGMP requirements

Experience in cGMP requirements, quality control, attention to detail, and excellent communication with other functional areas and sites

Preferred

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!

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

Company

Leiters Health

Leiters Health is a trusted FDA-registered 503B outsourcing provider of high-quality compounded sterile preparations and pharmacy services.

Founded in 1926

Englewood, Colorado, USA

201-500 employees

https://leiters.com/

H1B Sponsorship

Leiters Health has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)

Distribution of Different Job Fields Receiving Sponsorship

Represents job field similar to this job

Trends of Total Sponsorships

2024 (1)