Job Application for Specialist, Quality Operations

New

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 – Testing is responsible for quality assurance (QA) review of product testing 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 raw and in-process material, drug substance, and finished drug product testing, covering a broad range of analytical and microbial methodologies, while ensuring the adherence to applicable regulatory requirements and industry best practices.

Specific Duties:

Perform QA review of product testing 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
Author Braeburn GMP documentation such as, but not limited to, standard operating procedures (SOPs), change controls, specifications, stability protocols and reports, Certificates of Analysis (COAs)
Review and approve CTL activities, such as, but not limited to, release testing, stability storage and testing, and method development, validation, transfer, and verification protocols and execution
Review and approve Certificates of Analysis (COA), Stability Reports, and Method Reports generated by CTLs against raw data and/or specifications
Write and/or perform quality assessments and approval of 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
Maintain the Braeburn stability program and perform trend analysis
Assist in quality review of regulatory filings and annual product reviews
Participate in quality audits of CTLs and other vendors, as needed
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 5 – 10% of travel for audits and site visits at CSPs and/or other vendors, as needed

Education / Experience

Bachelor’s degree with focus in Chemistry, Biochemistry, Biology, or related field
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
Experience with analytical techniques such as chromatography (e.g., High Performance Liquid Chromatography (HPLC), Gas Chromatography (GC)) and spectroscopy (e.g., Fourier Transform Infrared (FTIR), Ultraviolet-visible (UV)), etc., and analyses such as assay, related substances and impurities, in-vitro release, etc. covering a broad range of dosage forms
Experience with microbial testing techniques and analyses for sterile dosage forms such as sterility, endotoxins, container closure integrity, etc.

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Specialist, Quality Operations – Testing

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