Since 1985, Belmar Pharma Solutions has been the compounding pharmacy of choice for healthcare providers who refuse to compromise on quality, consistency, and clinical support. We have been leaders in Women’s Health since our inception and continue to offer unsurpassed educational resources for women’s and men’s hormones, along with a dedicated Women’s Health team.
At Belmar, our benefits reflect our commitment to wellness, respect, and accountability. We offer comprehensive health coverage, a 401(k) with 5% match with no vesting period, paid time off and holidays, $500 referral bonuses, and access to free or reduced-cost prescriptions—because supporting our team enables us to deliver unmatched care.
The Quality Engineer is responsible for executing tasks and projects coordinating and performing quality assurance activitiesto accomplish the goals of the Quality Unit, Operations, and Belmar Select Outsourcing as a whole. This role shall execute tasks in accordance with company Standard Operating Procedures in addition to FDA and USP compliance standards. This position is also responsible for leading process improvement projects that align with goals of the Quality Unit, Operations, and Belmar Pharma Solutions as a whole. This position will report to the Lead Quality Engineer and the Director of QualityQuality Engineering Leader.
Responsibilities Include
- Authoring deviations, investigations, CAPAs, and Customer Complaints. Utilizing Root Cause Analysis tools. Providing organized updates to stakeholders.
- Provides technical approach to quality to support process improvement projects.Identifying, supporting, owning and implementing process improvement projects. This may include designing studies to gather and evaluate data.
- Preparing Change Controls. Communicating changes to stakeholders, including through training as applicable. Coordinating with other task owners to ensure the change is effectively implemented.
- Reviewing validation and qualification activities (protocols, final reports) for which the Quality Engineer is part of the Project Team.
- Preparing and presenting Quality Metrics and KPIs.
- Contributing to a professional, dynamic, cooperative, and high-achieving work environment for the team.
- Supporting day-to-day activities Quality response to production issues, for example, assessing Visual Inspection defects, supporting complex GDP corrections, evaluating raised issues to determine if a deviation is required, etc.
Qualifications And Education Requirements
- REQUIRED: Bachelor’s degree in scientific discipline (Engineering preferred)
- Ability to read and interpret regulatory guidance documents to learn and understand industry expectations and provide sound Quality input.
- Thorough understanding of applicable mathematics and scientific practices.
- Proficient in Microsoft Office Applications.
- Excellent communication skills, both oral and written. Ability to work in a team and/or independently. Emphasis in technical writing ability, however communication may include a variety of audiences (technicians, technical support staff, management, customers, etc.)
- Able to resolve conflicts and provide solutions.
- Must be able to function in a team environment.
- Must be able to read, understand and follow GMPs, SOPs, Specifications, and industry guidelines as they relate to the process.
- Time management skills and the ability to manage their workload and deadlines. Projects must be completed in a timely manner despite aggressive timelines.
Preferred Skills
- 1-2 years of experience and/or knowledge in a Pharmaceutical cGMP environment. Other regulated environments, or experience with manufacturing processes or equipment, or laboratory / analytical shall be considered.
- Experience in technical writing for multiple audiences.
- Familiarity with Six Sigma / DMAIC methodologies and the ability to apply them.
- Experience with Smartsheet, PowerBI, SharePoint, ACE or other Document Management Software, Adobe Acrobat.
Pay Range: $75,100 - $83,500