What are the responsibilities and job description for the Scientist I/II, Quality Control (QC) position at AbelZeta Inc.?
Job Description
The Scientist, QC position supports the Quality Control group at AbelZeta Rockville GMP facility for IND and Phase I/II GMP manufacturing. The role requires knowledge and experience of scientific concepts, practices, and procedures within the biopharmaceutical field and a cGMP environment. The QC Scientist will focus on supporting the routine operation of the GMP facility in analytical development, batch release, and stability studies, etc.
Responsibilities and Duties:
- Perform analytical testing applied by the QC Laboratory for evaluation of raw materials, components, and products at various stages of the manufacturing process following established ATMs or SOPs.
- Participate in activities as defined in method transfer/qualification/validation/stability study protocols.
- Review, analyze, interpret, and report data following GDP and ALCOA principles.
- Report and participate in investigations of deviation, OOS/OOT results, CAPA and other related activities.
- Author, review, and revise SOPs and ATMs, as necessary.
- Calibrate, validate, or maintain laboratory equipment when needed.
- Review and maintain laboratory data (including contract laboratories) to ensure accuracy and regulatory compliance.
- Perform other duties that may be assigned.
Qualifications and Requirements:
- Scientist I: Bachelor of Science (MS preferred) in a Life Sciences discipline with 1 years of relevant experience
- Scientist II: Master of Science in a Life Sciences discipline with 3-6 years of relevant experience or Bachelor's with 7 years of experience
- Sr. Scientist: Ph.D. in a Life Sciences discipline with 2 years of relevant experience
- 1-3 years of relevant experience working in a Quality Control work environment, preferably in the pharmaceutical industry with knowledge of cGMP is a plus
- Considerable expertise relevant to QC analytical methods used for cell therapy manufacturing including qPCR/dPCR, ELISA, flow cytometry or cell-based assays in a GMP environment.
- Experience in technical writing skills in SOPs and analytical test methods as well as method qualification/validation documentation.
- Excellent written/oral communication and interpersonal skills
Preferred Qualifications:
- Self-starter with superior analysis and problem-solving skills ranging from simple to sophisticated situations.
- Be proficient in MS Office suite.
- Demonstrates proficiency in current Good Manufacturing Practice (GMP).
- Possess good communication skills to explain information and influence others
- Must have a strong work ethic and demonstrate dependability and timeliness.
- Have a high energy level and a positive outlook coupled with the requisite “can do” attitude.
Why You Should Join AbelZeta
- Join a high-growth and fast-paced organization
- Defined career path and annual performance review and feedback process
- 100% company-paid Medical, Dental, Vision insurance
- Company 401K match up to 6%
- Paid holidays, sick leave, and annual leave
AbelZeta is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability. AbelZeta validates right to work using E-Verify.
Salary at AbelZeta is determined by various factors, including but not limited to location, the individual’s particular combination of education, knowledge, skills, competencies, and experience, as well as contract-specific affordability and organizational requirements. The estimate displayed represents the typical salary range for this position and is just one component of AbelZeta’s total compensation package for employees.
