Overview
Bravado Pharmaceuticals, a rapidly growing 503B outsourcing facility and CDMO, is seeking a Quality Assurance Specialist to support our expanding sterile and non-sterile manufacturing operations. This role is ideal for candidates with QA/QC experience in a regulated pharmaceutical environment who is ready to take on a critical position ensuring compliance with FDA cGMP standards, USP requirements, and 503B regulations.
Key Responsibilities
- Review and approve GMP documentation for investigations, batch production, packaging, analytical testing, etc.
- Lead or participate in formal risk assessment activities.
- Serve as the key point of contact for regulatory and client audits.
- Provide technical expertise for personnel training, deviations, CAPAs, cGMP compliance, data trending, raw material and finished product specifications, etc.
- Provide leadership and direction to Bravado personnel regarding quality and cGMP issues to ensure compliance with regulated standards.
- Participate in and/or lead continuous improvement of Bravado quality systems to ensure compliance with cGMP and industry standards.
- Develop and implement SOP's, standards, policies, and procedures for regulatory compliance.
- Other duties as assigned by management.
Qualifications
- Bachelor’s degree in chemistry, pharmacy, or a related science plus at least 5 years of progressive quality assurance experience within the pharmaceutical industry, or Master’s plus 3 years required.
- Demonstrated knowledge of cGMP regulations and ICH guidelines.
- Working knowledge of USP <797>/<795>/<800>.
- Strong documentation, organizational, and problem-solving skills.
- Ability to work effectively in a fast-paced, collaborative environment.
- Highly independent and self-motivated, but must integrate well with a team.
- Advanced knowledge of Microsoft Word and Excel.
- Applicants must be legally authorized to work in the United States.
Why Join Bravado?
- Be part of a dynamic and expanding CDMO/503B facility.
- Gain hands-on experience with regulatory compliance, sterile and non-sterile operations, etc.
- Competitive salary and benefits package.
- Growth opportunities in a company committed to excellence and innovation.
Job Type: Full-time
Work Location: In person
