JOB DESCRIPTION:
Serve as a key resource for the generation of quality metrics and process improvement for the Quality Unit.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
- Assist with the implementation and maintenance of Quality Management Systems (QMS).
- Manage Corrective Action and Preventive Action responses received for internal and vendor audits, and responses defined for external audit observations. Conduct follow-up with the applicable departments to ensure timelines for corrective actions are met.
- Assist with the development, generation and distribution of KPIs and other key quality metrics.
- Create and documentation of new flows, procedures, documents, training, and other support materials.
- Responsible for assisting Quality Unit with updates to Standard Work Instructions and Standard Operating Procedures.
OTHER DUTIES AND RESPONSIBILITIES:
- Manages multiple QA tasks in parallel and effectively prioritizes tasks to align with corporate quality objectives.
- Effective time management, tracking deliverables and when necessary, escalations to supervisor.
QUALIFICATIONS AND SKILLS NEEDED:
- Exceptional written and verbal communication skills, attention to detail
- Strong working knowledge of editing, proofreading, spelling, grammar, and punctuation
- Skilled at organizing information into a clear and concise written form
- Ability to work independently as well as in a team environment
- Proficient in Excel
EDUCATION:
- Bachelor's Degree, preferably in a Scientific or Technical Field
EXPERIENCE:
- Knowledge of 21CFR Part 11, 21 CFR 820.20, ISO 9001/13485 and applicable regulatory authorities preferred.
- Must have 2 to 5 years of related experience, within an FDA regulated industry environment.
- Must have prior experience in a Quality Assurance role. Knowledge of GDP and GCP required.
- Experience with Quality Management Systems, QE and CAPA management highly preferred.
- Clinical trial experience preferred
Company Description
About BCforward:
Founded in 1998 on the idea that industry leaders needed a professional service, and workforce management expert, to fuel the development and execution of core business and technology strategies, BCforward is a Black-owned firm providing unique solutions supporting value capture and digital product delivery needs for organizations around the world. Headquartered in Indianapolis, IN with an Offshore Development Center in Hyderabad, India, BCforward’s 6,000 consultants support more than 225 clients globally.
BCforward champions the power of human potential to help companies transform, accelerate, and scale. Guided by our core values of People-Centric, Optimism, Excellence, Diversity, and Accountability, our professionals have helped our clients achieve their strategic goals for more than 25 years. Our strong culture and clear values have enabled BCforward to become a market leader and best in class places to work.
BCforward is an equal opportunity employer.