QA Specialist - (Bioassay & Analytical Lab experience)
Just – Evotec Biologics, wholly-owned by Evotec SE, is a unique platform company that integrates the design, engineering, development, and manufacture of biologics. With deep experience in the fields of protein, process and manufacturing sciences, the Just team came together to solve the scientific and technical hurdles that block access to life-changing protein therapeutics; from the design of therapeutic molecules to the design of the manufacturing plants used to produce them. Just's focus is to create access and value for a global market through scientific and technological innovation.
QA SPECIALIST - (BIOASSAY & ANALYTICAL LAB EXPERIENCE)
Just is seeking a highly motivated and self-directed Quality professional who desires a significant opportunity to improve worldwide access to biotherapeutics. In this position, you will work as a member of a small highly experienced and innovative team to ensure high quality standards for the safe and reliable production of biological products.
This position will be responsible to support the QC Lab Operation activities regarding documentation approval, initial deviation investigation, environmental monitoring, and testing to ensure compliance with all regulatory requirements, company policies, values, and goals.
Responsibilities:
Review the QC analytical testing and method transfer documents to ensure compliance with all regulatory requirements, company policies, values, and goals.
Responsible for quality record review such as CAPAs, Stability protocols/reports, and other quality documents as required.
Responsible for supporting process improvements within the Operations organization.
Responsible for supporting or driving cross-training across QC Labs.
Responsible for inspection support for QA QC Site department as required.
Partners with other QA peers to ensure consistency and efficiency within the QA department.
This position requires strong collaboration skills, including working with Process Development, Quality Control, Engineering, Site Technical Operations, other sites, and others to ensure timelines are met for activities related to Quality Control and the Site.
Continue to build and enhance various Quality Assurance programs by guiding individuals through the maturation process.
Support implementation of phase appropriate programs that allow technical and scientific flexibility depending on the stage of the clinical program.
Alert senior management of significant quality, compliance, supply, and safety risks
Educational Requirements:
- Bachelor’s degree in chemical or biological science with 3-5 years relevant experience
Preferred Qualifications:
Quality Control working experience – preferably in documents revision and approval level.
OOS and investigation experience.
Experience in helping to build and maintain a Quality infrastructure in a fast-paced growing company.
Comprehensive understanding of biologics regulatory requirements, risk management principles, and science-based decision making.
Experience in laboratory testing such as: SEC UHPLC, Potency and Residual Protein (ELISA), Osmolality, Solo VPE, Capillary Electrophoresis (SDS/rCE-SDS), Assay (icIEF).
Experience in release testing, stability testing, equipment qualification, and method qualification.
Experience in tools, concepts, and methodologies of QA.
Strong computer skills including Microsoft Office and eQMS databases, including LIMS, CMMS, MES.
Key competencies in verbal and written communication; attention to detail; data collection, management, and analysis; judgement and decision making; and building teams.
The base pay range for this position at commencement of employment is expected to be $90,000 to $125,000; Base salary offered may vary depending on individual’s skills, experience and competitive market value. Additional total rewards include discretionary annual bonus, comprehensive benefits to include Medical, Dental and Vision and 401k company match, flexible paid time off and paid holiday, wellness and transportation benefits.
Evotec (US) Inc. is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, gender, age, disability, genetic information, gender expression, gender identity, national origin, religion, sexual orientation, or veteran status.
