What are the responsibilities and job description for the QC Associate II, Analytical position at Abzena Inc.?
With extensive experience in developing biologics and bioconjugates, we offer a seamless service delivered by fully integrated teams, from early discovery to commercial manufacturing.
Forward-thinking and committed, we find the best solution and use the right technologies to design, develop and manufacture your products to ensure we get vital medicines to patients quickly and safely.
We are dedicated to quality excellence. We are driven to get better treatments to market, efficiently and responsibly by reducing timelines and delivering the highest quality products and services.
We are Abzena. More than a CDMO, we are a responsible and dedicated partner that takes care of your products from concept to patient.
The Quality Control Associate II is responsible for routine testing of incoming raw materials and product, (e.g. in-process, release, stability, etc.) in support of GMP manufacturing at Abzena. Focus areas include execution of analytical method qualification/validation protocols, routine analytical testing and documentation/data review of QC generated results. The associate will perform a variety of responsibilities in both a team and individual setting.
Responsibilities
- Performance of QC raw material, in-process, drug substance and drug product testing for release and stability, as well as support of testing/review of data with/from contract testing laboratories (e.g. compendial methods, HPLC, ELISA, CE, fluorescence assays, particle sizing, bioburden, endotoxin, etc.).
- Provides critical QC centric review of draft Analytical Test Methods (ATMs) and qualification/validation protocols received from the Analytical Method Development (AMD) group.
- Executes qualification/validation protocols and writes technically sound qualification/validation reports.
- Participate in method and equipment qualification and validation in the QC laboratory.
- Provide review of QC data and associated documentation.
- Support laboratory investigations to determine root cause for OOS, OOT, Atypical and invalid test results.
- Contribute to laboratory operations by performing regular instrument calibration and minor instrument maintenance.
- Support operational systems (e.g. equipment maintenance, reagent prep, forms control, etc.).
- Train on all relevant procedures, as appropriate.
- Operate to the highest ethical and moral standards.
- Demonstrate flexibility with changing priorities.
- Apply a working knowledge of compendia testing (USP, Ph. EUR, JP, etc.) wet chemistry techniques and analytical analysis (U/HPLC, CE, cIEF, ELISA, SDS PAGE, etc.).
- Contribute to Quality Control department goals and objectives.
- Comply with Abzena's policies and procedures.
- Communicate effectively with clients, supervisors, colleagues and staff.
- Participate effectively as a team player in all aspects of Abzena's business.
- Adhere to quality standards set by regulations and Abzena policies, procedures, and mission.
- Perform other related duties as assigned.
Qualifications
- B.S. or Associates and Certificates plus 2 years’ experience.
- 2-5 years of experience in a GMP Laboratory setting.
- Knowledge of the theoretical and practical aspects of analytical methods utilized to characterize large molecule therapeutics including U/HPLC, CE, cIEF, ELISA, SDS-PAGE and all compendial testing.
- Experience with preparing analytical test reports, qualification/validation protocols, qualification/validation reports and SOPs.
- Familiarity with compendia (USP, Ph. EUR, and JP) and ICH guidelines.
- Strong written and oral communication skills, proficiency with Microsoft Office software.
FLSA: Exempt
Abzena is an equal opportunity employer that is committed to diversity and inclusion in the workplace. We prohibit discrimination and harassment of any kind based on race, color, sex, religion, sexual orientation, national origin, disability, genetic information, pregnancy, or any other protected characteristic as outlined by federal, state, or local laws.
This policy applies to all employment practices within our organization, including hiring, recruiting, promotion, termination, layoff, recall, leave of absence, compensation, benefits, and training.
