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COMPANY:
At BioCryst, we share a deep commitment to improving the lives of people living with complement-mediated and other rare diseases. For over three decades we've been guided by our passion for not settling for "ordinary" in our quest to develop novel medicines. We leverage our expertise in structure-guided drug design to develop first-in-class or best-in-class oral small-molecule and protein therapeutics, led by the efforts of our team of expert scientists in our Discovery Center of Excellence in Birmingham, Alabama. Our global headquarters is in Durham, North Carolina, our European headquarters is in Dublin, Ireland and our employees span the globe across sites in multiple countries. 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 our website at www.biocryst.com or follow uson LinkedIn and Instagram.
JOB SUMMARY:
The Sr. Quality Assurance (QA) Specialist is responsible for ensuring compliance with BioCryst's Quality Systems in support of small and large molecule drug substance and drug product manufacturing/packaging and testing performed at Contract Manufacturing Organizations (CMOs). 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, OOS/OOT investigations, change control, document control, training, validation, internal audits, vendor management, stability program, API receipt and control, cell bank manufacturing, bulk drug substance and drug product manufacturing, packaging and labeling of drug product, and testing of drug substance and drug product for clinical and commercial distribution. This role has high visibility throughout the organization and therefore requires close coordination across multiple groups with-in BioCryst, e.g., Pharmaceutical Development, QA, QC, Clinical, Regulatory, Safety, Supply Chain and Finance. #LI-Remote
ESSENTIAL DUTIES & RESPONSIBILITIES:
EXPERIENCE & QUALIFICATIONS:
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.
Full Time
Pharmaceutical
$98k-118k (estimate)
08/30/2023
10/10/2024
biocryst.com
HOOVER, AL
200 - 500
1986
Public
TAMI WARREN
$50M - $200M
Pharmaceutical
BioCryst is a biotech company that discovers and develops novel small molecule therapeutics for patients with rare and serious diseases.
The job skills required for Sr. QA Specialist include Quality Assurance, SOP, Quality Control, Supply Chain, Internal Audit, Chemistry, etc. Having related job skills and expertise will give you an advantage when applying to be a Sr. QA Specialist. That makes you unique and can impact how much salary you can get paid. Below are job openings related to skills required by Sr. QA Specialist. Select any job title you are interested in and start to search job requirements.
The following is the career advancement route for Sr. QA Specialist positions, which can be used as a reference in future career path planning. As a Sr. QA Specialist, it can be promoted into senior positions as a Quality Assurance Specialist IV that are expected to handle more key tasks, people in this role will get a higher salary paid than an ordinary Sr. QA Specialist. You can explore the career advancement for a Sr. QA Specialist below and select your interested title to get hiring information.