QUALITY ASSURANCE SPECIALIST (BRIS 1.108)
This role will support the Director of Quality Assurance with various day-to-day QA operations and quality systems management. As a small, early development company, there will be broad exposure and experience to gain in all areas of Quality Assurance, as well as opportunities for cross-functional exposure, input into team and company policies, interaction with high-level executives, and a healthy helping of good, clean fun.
The ideal candidate (yes, you) should be able to manage moderately complex activities where judgment is required in resolving problems and making recommendations. Experience in a biotech or pharmaceutical development company and knowledge of cGMP quality systems is preferred, but if you’re the sort of go-getter who can learn on the fly, don’t hold back. You should be independent, proactive, and typically require little instruction on routine work. You’ll provide recommendations for new assignments/opportunities and escalate concerns and issues to senior management appropriately. You should be proficient in Microsoft Office applications and, more importantly, delight in learning new software/computer systems. A willingness to work hard, try new things, keep learning (including from failures), smile authentically, and maintain a positive outlook as part of your job are key to your success.
Here's What You’ll Do:
- Support the management of UNITY’s electronic Quality Management System, including Document and Training management.
- Perform a wide variety of activities related to various quality systems to ensure compliance with applicable quality objectives, current Good Manufacturing Practices (GMPs) and applicable regulatory requirements.
- Apply company policies and procedures to resolve a variety of moderately complex issues. Exercise good judgment in selecting methods and techniques within defined procedures and practices to determine appropriate action.
- Keep abreast of requirements for compliance. Participate (as required) in training on regulatory issues affecting your own area of work. Notify your manager of compliance questions and issues.
- Write, review, and/or approve GMP documentation (SOPs, protocols, technical reports, specifications, summary reports to support GMP production, change controls, validation, etc.).
- Collaborate with internal and external customers to resolve quality events and deviations.
- Growth opportunities include Supplier Management and Audit, Person in Plant.
- Demonstrate infectious enthusiasm and optimism, spreading cheer and good will everywhere you go. Like Santa Claus riding a unicorn.
- Ability to perform detail-oriented work with a high degree of accuracy
- Excellent verbal, written, and interpersonal communication skills
- Effective time management, organizational, and planning skills
- Initiative and proactive behavior
- Development of productive internal and external working relationships
- Effective teamwork within groups with rapidly changing priorities
- Flexibility, good coping skills and analytical problem-solving skills
- Experience with computer systems, databases, and an advanced knowledge of the Microsoft suite (i.e. Word, Excel, Visio, PowerPoint, etc.)
- BA/BS or equivalent combination of related education and experience and at least 5 years of relevant experience in the pharmaceutical/biotech industry or equivalent combination
- Bonus skills:
- Experience in electronic quality system management, document management and training
- Proficiency in the application of QA systems principles and standards, current industry practices, and applicable regulations including 21 CFR Parts 210, 211, 600, Eudralex Volume 4 and related annexes
- Do you bake cookies? We love cookies. Not a deal-breaker. We’re just sayin’.