Quality Assurance Associate II Job in Waltham 02451, Massachusetts US
General Accountability:
The Quality Assurance Associate reports to the Director of QA/QC. Has direct QA responsibilities to include, but not limited to: Authoring, revising, and reviewing cGMP procedures, reviewing batch records and supporting documentation for final product release, deviations, CAPA investigation, Tracking Supplier Management Program and Internal Audit Program.
Responsibilities:
- Develop and lead initiatives that improve quality, product and/or compliance-related lab processes and systems.
- Perform data analysis to support investigations or improvements.
- Lead root cause analysis investigations
- Review and approve equipment and test method qualifications. Identify and implement better validation approaches and utilize FMEA, DOE, process capability and other improvement tools.
- Provide compliance direction pertaining to regulatory requirements surrounding facility, and manufacturing.
- Perform internal audits for cGMP and quality system compliance
- Provide support during Regulatory/Health Authority agency audits (FDA, EU,).
- Perform AQL inspection while identifying compliance issues and providing recommendations for improvements.
- Familiar with operating procedures, quality and regulatory requirements pertinent to biological, and medical devices.
- Must be able to apply sound scientific principles and compliance standards to quality projects.
Requirements:
- A minimum of a Bachelor's degree in a scientific area.
- 3 - 5 years of related work experience preferred
- Experience in an Orthopedic, pharmaceutical or biologics environment.
- Knowledge of ISO, FDA and cGMP concepts and guidelines.
- Ability to communicate effectively, verbally and in writing, and demonstrate good interpersonal skills interdepartmentally
- Very Strong analytical problem solving and organizational ability.
- Candidate must be flexible and able to adapt to changes in priorities
- Demonstrated ability to work accurately, follow instructions/schedules/timelines and handle multiple priorities.
- Professional, well-organized, and eager to learn and be challenged.
- Must have excellent MS Office applications Word, Excel, Access, Power Point as well as Adobe Acrobat skills.
- Works under minimal supervision
May 11, 2009
• Tags: Massachusetts Us, Quality Assurance Associate II Job in Waltham 02451 • Posted in: General