Sr. QA Specialist

BioCryst

Posted on: June 20, 2022

Closing: July 20, 2022

Salary: Undisclosed

Position Type: Full Time

Job Description

At BioCryst, we are passionate about advancing novel therapeutics for patients with rare and serious diseases. Our structure-guided drug design process leads us to the discovery and development of novel small-molecule drugs. We integrate traditional biology and medicinal chemistry along with a wide array of advanced technologies to understand the three-dimensional structures of active sites of target enzymes. Our scientists then design molecular structures to create bespoke drugs for patients. We focus on therapeutic areas with either no available treatments or large unmet patient needs. BioCryst’s US headquarters are located in Durham, North Carolina, our European headquarters in Dublin, Ireland and our Discovery Center of Excellence in Birmingham, Alabama. We are proud of our culture of engagement and accountability that rewards people for innovative thinking and achievement of key objectives. For more information, please visit the Company’s website at www.biocryst.com.

JOB SUMMARY:

The Sr. Quality Assurance (QA) Specialist is responsible for ensuring compliance with BioCryst’s Quality Systems in support of drug substance and drug product manufacturing and testing performed at Contract Manufacturing Organizations (CMOs). Reporting to the QA Manager at BioCryst’s Birmingham, AL site. The Sr. QA Specialist will be responsible for ensuring compliance with BioCryst SOPs and Policies for all outsourced and internal GMP activities. The Sr. QA Specialist will coordinate and execute the batch review process with internal reviewers to ensure compliance to cGMP. Functions include QA oversight and support for deviations, investigations, document control, training, validation, internal audits, vendor management, stability program, API receipt and control. #LI-Remote

ESSENTIAL DUTIES & RESPONSIBILITIES:

• Performs all responsibilities in accordance with US and European Drug Substance and Drug Product GMP regulations and associated guidelines, appropriate to the phase of development.
• Review cGMP documentations, including, but not limited to master and executed records associated with drug product, drug substance, packaging, and labeling.
• Disposition of drug substance, drug product and packaged/labeled product for clinical and commercial distribution
• Provides Quality guidance in the resolution of deviations, investigations, and out-of-specification events. Conduct, review and/or approve deviations/investigations.
• Review of primary and secondary packaging and labeling MBRs and EBRs.
• Reviews process validation protocols and reports including analytical test results to ensure compliance with approved specifications.
• Ensures studies, qualifications, and validations are performed per the protocol.
• Reviews internal developmental study protocols and reports.
• Assists in hosting audits and regulatory inspections.
• Assists with preparation and performance of internal audits.
• Participates in internal and external project team meetings.
• Oversees training activities and prepares training documentation.
• Writes and reviews SOPs and Quality Assurance procedures.
• Participates in qualification of CMOs and monitoring of CMO’s performance.
• Presents/participates in GMP/GLP training sessions.

 

EXPERIENCE & QUALIFICATIONS:

• Minimum of bachelor’s degree required.
• Minimum of five (5) years of pharmaceutical experience in QA Operations, Manufacturing, QC and/or other relevant operational areas required.
• Understanding of pharmaceutical CMO relationships. Experience performing vendor and internal audits.
• Experience in the identification and resolution of GMP quality and compliance issues.
• Knowledge of Root Cause Analysis Techniques to support manufacturing and/or Analytical Investigations, CAPA, and Risk Evaluations.
• Experience in implementation and administration of quality systems for drug substance and drug product development, manufacturing, and quality control operations from early phase.
• Experience in early phases of drug development, from non-clinical toxicology studies to registration and process validation.
• Extensive knowledge of US and European Drug Substance and Drug Product GMP requirements and associated guidelines.
• Team player committed to quality; motivated self-starter; detail and results oriented; well organized, efficient worker with good communication skills.
• Strong written and oral communication skills; ability to manage multiple projects at one time.
• Excellent attention to detail; experience with QA review of batch records, analytical data, method development protocols, deviations, stability data.

 

The statements in this position description are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not intended to be construed as an exhaustive list of responsibilities, duties, and skills required of personnel so classified. The manager may assign additional responsibilities and assignments from time to time.

BioCryst is an equal opportunity employer and is committed to providing equal employment opportunities without regard to age, race, religion, sex, sexual orientation, gender identity, national origin, Veteran’s status, disability and/or other protected class characteristics. Additionally, BioCryst is committed to achieving its business objectives in compliance with all federal, state and local law.

BioCryst

Posted on: June 20, 2022

Closing: July 20, 2022

Salary($): Undisclosed

Position Type: Full Time

Career Focus: Manufacturing, Operations, Quality

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