MSAT Specialist

MSAT Specialist Belmar Pharma Solutions - 2.4 Golden, CO Job Details Full-time 15 hours ago Benefits Paid holidays Health insurance Paid time off 401(k) 5% Match 401(k) matching Referral program Qualifications Content creation for technical audiences Technical writing within manufacturing Math Bachelor's degree Regulatory compliance analysis Achieving project delivery timelines Standard operating procedures (SOPs) Full Job Description 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 Manufacturing Science and Technology (MSAT) department reports through Operations and owns the scientific and technical oversight of the commercial manufacturing processes. This team acts as a bridge between Production and other groups, including but not limited to R D Product Management, Quality Assurance, Quality Control, and Process Engineering, to ensure the company develops and maintains compliant, robust, efficient, and maintainable manufacturing processes. The MSAT Specialist is responsible for executing tasks and projects to accomplish the goals of Operations in collaboration with the Quality Unit and Belmar Select Outsourcing as a whole. This role shall execute tasks in accordance with company Standard Operating Procedures in addition to all applicable federal and state regulations.

Responsibilities:

Authoring deviations and investigations utilizing Root Cause Analysis tools. Providing organized updates to stakeholders. Implementing corrections Authoring and maintaining Production SOPs, Work Instructions. Identifying and supporting process improvement projects. Preparing production Change Controls. Communicating changes to stakeholders, including through training as applicable. Implementing changes and coordinating with other task owners to ensure the change is effectively implemented. Preparing and presenting Operations Metrics and KPIs and taking action to reduce waste and/or improve capacity, yield, technology, or other operational efficiencies. Contributing to a professional, dynamic, cooperative, and high-achieving work environment for the team. Supporting day-to-day activities response to production issues, for example, assessing Visual Inspection defects, supporting complex GDP corrections, evaluating raised issues to determine if a deviation is required, engaging the appropriate other cross-functional teams such as QA for involvement, etc. Performing physical walkthroughs of the Production spaces to ensure audit readiness and cGMP compliance, and addressing or escalating findings. Supporting audits, including providing documents and information during the audit, and addressing Production related observations.

Qualifications & Expereince:

REQUIRED

Bachelor's degree in scientific discipline 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:

Minimum 1 year 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. Experience with reading and interpreting regulatory guidance documents.