- Implement / execute computer system validation and general CQV.
- Work with site facility and operations teams to ensure compliance with Validation Master Plan activities.
- Provide support for change control technical assessment/evaluation process.
- Align on change control requirements to manage the requested change.
- Implement qualification procedures.
- Responsible for system compliance aspects across the site's project portfolio.
- Support the site's quality system management with measurement and control strategies.
- Support regulatory inspections and audits.
- Manage the risk assessment process for qualification and validation.
- Support vendor qualification and compliance audits.
- Review technical/investigation reports as appropriate.
- Write, review, and approve proposed changes to systems and procedures, as appropriate.
- Write, review, and approve protocols and summary reports.
- Track, review, and report metric information for use in continuous improvement of areas of responsibility.
- Support QE Director on continuous improvement initiatives and projects within the site's quality organization.
- Perform other duties and tasks as assigned.
- Bachelor's degree in technical discipline (Computer Science/ Industrial Engineering or similar).
- Minimum of 3 years of Quality Engineering with related experience such as Computer System Validation in a GMP environment (Drug Substance or Drug Product).
- Knowledge of quality systems and pharmaceutical regulatory requirements (21 CRF Part 11/210/211, ICH 8, ICH 9, and ICH 10).
- Quality Engineering Certification, ASQ, Black Belt/Green Belt certifications, preferred.
- Proficiency in Computer System Validation in a GMP environment (Drug Substance or Drug Product).
- Automation, equipment, and utility IQ/OQ/PQ/PV.
- Quality Assurance, GMPs, Health Authority Regulations and Validation practices/principles.
- Strong knowledge of GMP, GAMP, SOPs, and quality systems.
- Experience with internal and external audit principles.
- Strong knowledge of change control practices/strategies.
- Proficient in MS Word, Excel, PowerPoint, and other applications.
- Ability to communicate and work independently with scientific/technical personnel.
- Strong communication and coordination skills, good language skills and the ability to analyze and solve problems with a positive work attitude.
- Ability to work in a dynamic, fast paced environment with shifting priorities
- Ability to work collaboratively with teams and collaborators.
- Join a high-growth and fast-paced organization.
- Defined career path and annual performance review and feedback process.
- Comprehensive Benefits Plan, including 100% company paid medical, dental, vision, life Insurance, short-term and long-term disability insurance, and more
- Competitive company 401k match.
- Paid holidays, sick leave, and annual leave.
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Manager, Quality Engineering - Rockville, United States - AbelZeta Inc
Description
Job Description
Job DescriptionAbelZeta is a clinical stage biopharmaceutical company focused on the development of novel cancer immunotherapy products. AbelZeta operates a state-of-the-art facility in Rockville, Maryland with five GMP rooms in order to augment its global research and development capabilities and to support clinical development of multiple cell therapy platform technologies in the US. We are on a rapid growth trajectory and have a highly energized and accomplished team driving to new frontiers of care for cancer patients. We are seeking a Manager / Sr. Manager, Quality Engineering to join our team.
This position responsible for supporting the site Technical Operations (TechOps) processes related to cGMP such as Commissioning, Qualification and Validation (CQV), Computer System Configuration Management and Computer System Validation (CSV). This position ensures compliance with Abelzeta's procedures and all applicable regulatory guidelines. Assisting with the commissioning and qualification of AbelZeta's manufacturing site, providing support to the site validation group tasked with implementation of new equipment and manufacturing suites. Maintaining the Validation Master Plan.
Responsibilities and Duties:
Qualifications and Requirements:
Why You Should Join AbelZeta
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.
