Location: Plymouth Meeting,PA, USA
Reports to: Director, Quality Operations
Location: Plymouth Meeting, PA (Hybrid)
Company Overview:
Braeburn is dedicated to delivering solutions for people living with the serious consequences of opioid use disorder. At Braeburn, we challenge the status quo and champion transformation of the management of opioid use disorder (OUD) by partnering with the community to create a world where every person with OUD gets the best possible care and opportunity to reach their full potential. Our shared commitment to innovation on behalf of patients enables us to help people with OUD begin and sustain recovery.
At Braeburn, there are opportunities to contribute to our purpose every day. We value authenticity and strive to amplify all voices. Our culture empowers everyone to be successful and unleashes our full potential.
Position Summary:
The Specialist, Quality Operations - Manufacturing is responsible for quality assurance (QA) review of product manufacturing activities at Contract Service Providers (CSPs) involved in current Good Manufacturing Practices (cGMP) for Braeburn's marketed and pipeline products. This individual will perform quality and compliance review of batch production documentation, while ensuring the adherence to applicable regulatory requirements and industry best practices.
Specific Duties:
* Perform QA review of batch production documentation and activities under current Good Manufacturing Practices (cGMP) operations for Braeburn's clinical and commercial products
* Ensure all CSPs (e.g., Contract Development Manufacturing Organizations (CDMOs), Suppliers, Contract Testing Laboratories (CTLs), Distributors) meet quality expectations and GMP standards through manufacturing, testing, and batch release
* Review and approve product related GMP documentation generated by CSPs, such as, but not limited to, change control, executed production records, and qualification/validation protocols and reports
* Write and/or perform quality assessments and assist with product related deviations, complaints, and out-of-specification/out-of-trend investigations conducted internally and/or by CSPs, ensuring root cause(s) is appropriately identified, impact is adequately assessed, and robust CAPA is applied
* Author Braeburn GMP documentation such as, but not limited to, standard operating procedures (SOPs), change controls, protocols, and reports
* Assist in quality review of regulatory filings and annual product reviews
* Participate in quality audits of CDMOs and other vendors, as needed
* Participate and/or conduct Risk Assessments applicable to product design, processes, investigations, or other needs as seen fit
* Participate in inspection readiness for QA topics, and assist and participate during regulatory inspections and internal audits
* Other job responsibilities as required
Skills:
* Strong written and oral communication skills
* Attention to detail with the ability to perform critical review of various types of documents
* Organized, flexible, and easily adaptable to changing conditions
* Ability to work well in high pressure situations to meet deadlines
* Ability to work in a hybrid (office and remote) setting with 10 - 20% of travel for audits and site visits at CSPs and/or other vendors, as needed
Education / Experience
* Bachelor's degree in a science discipline or related field preferred
* 1+ years' experience in cGMP environment within relevant functions with degree, or 3+ years' experience in cGMP environment within relevant functions without a degree.
* Knowledge of cGMP regulations
Braeburn is committed to ensuring equal employment opportunity for all qualified applicants regardless of race, color, religion, sex, sexual orientation, gender identity, national origin, military/veteran status, age, disability, or any other category/characteristic protected by law (collectively, Protected Categories ). In fact, we encourage all underrepresented backgrounds to apply for any open job positions with the company.