Senior Quality Engineer

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 Senior Quality Engineer is critical in ensuring that products, processes, and procedures meet USP, FDA, ISO, and cGMP standards. The Senior Quality Engineer collaborates with cross-functional teams including production, engineering, and quality control to identify potential quality issues and implement effective corrective actions. This role requires a strategic thinker who can serve as the senior quality assurance representative for document review, implementation of new equipment/processes, on‑floor questions, and other quality functions. The Senior Quality Engineer reports to the Quality Assurance Manager. Responsibilities Reviewing and approving deviations, investigations, and CAPAs while ensuring compliance with regulations. Authoring quality deviations and escalating to root cause analysis and CAPA when required. Reviewing and approving requested document updates for the site. Reviewing and approving Change Controls as the Senior Quality Assurance approver. Reviewing and approving validation and qualification activities (protocols, final reports) to support company, equipment, product and/or performance processes. Executing, providing guidance, and overseeing department‑wide Quality Systems, metrics and reporting, for example Customer Complaint Response & Evaluation, Quality Metric and KPI administration & presentation, and similar. Supporting job interviews, motivation, coaching, and training in coordination with the Quality Engineering Leader. Providing a professional, dynamic, cooperative, and high‑achieving work environment for the staff. Supporting Quality Engineering Leadership by coaching other QEs in skills related to technical skills, management and leadership. 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. Physical Requirements Position requires use of necessary equipment such as computers, scanners, or other technology devices as assigned. Must be able to work in a variety of positions and locations such as sitting, standing, squatting, kneeling, reaching, and walking for prolonged periods of time. Position requires handling of laboratory chemicals or hazardous materials. Position requires infrequent gowning into ISO classified spaces. This requires removal of makeup, jewelry (rings, piercings, etc.), and items that shed. This may also require wearing PPE for long periods of time. Position requires infrequent lifting of up to 50 lbs. Qualifications REQUIRED: Bachelor’s degree in engineering (Chemical, Mechanical, Manufacturing, Electrical, or Software). Other STEM degrees shall be considered with applicable work experience. REQUIRED: Experience in a Pharmaceutical cGMP environment, including a sufficient understanding of industry expectations to independently provide sound Quality input and decisions. Experience supporting manufacturing operations through implementing improvements to support production processes. Proficient in Microsoft Office Applications. Excellent communication skills, both oral and written. Ability to work as part of a team and/or independently and provide leadership. Emphasis in technical writing ability, however communication may include a variety of audiences (technicians, technical support staff, management, customers, etc.) Ability to resolve conflicts and provide solutions. Must be able to read, understand and follow cGMPs, SOPs, Specifications, and industry guidelines as they relate to the process. Time management skills and the ability to manage oneself. Projects must be completed in a timely manner despite aggressive timelines. Preferred Skills 3-5 years of experience and/or knowledge of pharmaceutical processes, systems, equipment, and applicable government regulations. Experience managing Quality Systems, especially Deviation, Investigation, CAPA, and customer complaints. Familiarity with industry guidance and regulation documents, for example FDA Guidance for the Industry, 21 CFR 211, USP, ISO Manufacturing. Experience with Smartsheet, PowerBI, SharePoint, ACE or other Document Management Software, Adobe Acrobat. Experience with Validation (Process Validation, Equipment IQ/OQ/PQ). Pay Range $88,400 - $95,900 Equal Employment Opportunity Statement We are an equal employment opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status or any other characteristic protected by law. This position is currently accepting applications. #J-18808-Ljbffr Belmar Pharma Solutions