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Mid LevelFull-time
Salary Range
$102,000 - $138,000 /year
This salary is estimated based on similar roles. The actual salary may vary.
About the Role
Serán BioScience is seeking a Quality Assurance Engineer to join their expanding team. This role involves reviewing and approving qualification/validation activities across the lifecycle of facilities, utilities, equipment, process, cleaning, and computerized systems, with a focus on supporting the Commercial Manufacturing Facility.
Key Responsibilities
- →Generate and support the creation of risk assessments, user requirements specifications (URS), C&Q plans, change controls, SOPs, CAPAs, and other relevant documents
- →Support validation lifecycle activities including change management, periodic reviews, and re-qualification
- →Make compliance decisions to support commercial operations
- →Mentor colleagues on requirements and practices
- →Drive process improvement initiatives
- →Provide support during client and regulatory audits
- →Perform other related duties as assigned
Requirements
- ✓Understanding of current regulations and guidelines (21 CFR Parts 11, 210, 211, EudraLex Volume 4 - Annex 15, GAMP 5)
- ✓Technical writing skills for developing procedures and documents
- ✓Hands-on experience with qualification of facilities, utilities, equipment, and/or computerized systems, cleaning or process validation
- ✓Ability to manage multiple projects, solve problems, and work within a cross-functional team
- ✓Strong time-management and interpersonal skills
- ✓Bachelor’s degree in a science, engineering, or related field
- ✓Minimum of 4 years of experience within the pharmaceutical industry
- ✓Minimum of 4 years of experience performing qualifications and/or validations
Benefits
- ★Over four weeks of paid time off annually
- ★Employer contributions to a retirement account after 90 days
- ★Various health plans with minimal employee contributions
- ★Basic life and long-term disability insurance
- ★Employee Assistance Program
- ★Pet insurance
