The Quality Assurance Specialist/Technical Writer will support the Corporate Resource Manager who is responsible for Quality Assurance, Regulatory Affairs and Human Resources. This position will include responsibilities and support in these key areas:
Essential Job Duties and Responsibilities
- Coordinate the review and processing of all Standard Operating Procedures (SOPs) and controlled documents.
- Support the BBCS change management system for all documentation updates.
- Support each department by collaborating with department managers to ensure each procedure is of quality standards.
- Provide general document review, guidance and editing to support current standards.
- Perform updates to the internal Employee Help website.
Other Job Duties
- Support and maintain internal audits and associated records.
- Support and maintain Corrective and Preventive Actions (CAPAs) and associated records.
- Assist with FDA audit preparation and documentation.
- Coordinate human resources activities to include: employee recruitment and hiring processes, employee training, employee benefits, employee performance evaluations, employee recognition and PTO.
- Maintain all employee personnel files in compliance with legal requirements.
Qualifications and Experience
- Attention to detail, accuracy and timely follow-through.
- Must have technical writing experience.
- Strong communication skills, both verbal and written.
- Highly organized and able to manage multiple priorities and deadlines.
- Must be proficient in Microsoft Office applications.
- Ability to maintain highly confidential information.
- Analytical and problem solving skills.
- Experience working in a software development or medical device environment a plus.
- A working knowledge of CFRs and work with regulatory agencies a plus.
- A BS degree in technical writing, business or other related area. Minimum of two (2) years of experience with QA and SOP creation/management.
As an employee within our company, this position will participate with other staff members to contribute to and support the corporate goals, business plan, Standard Operating Procedures and Corporate Quality Policy, and thus requires personal and professional integrity and work ethics. Attendance and punctuality are paramount for this position.
Blood Bank Computer Systems, Inc. (BBCS) is located in Auburn, WA with a mission to serve the health care industry around the country through integrated technologies and unwavering support solutions. BBCS currently supports the blood and tissue industry in 18 states.
BBCS is looking for positive, passionate people to join our team. We offer competitive benefit packages including: Health Benefits, Profit Sharing, 401k matching, Paid Time Off, and the employee favorite half day Fridays during the summer.
The statements contained herein reflect general details as necessary to describe the principal functions of this job, the level of knowledge and skill typically required and the scope of responsibility, but should not be considered an all-inclusive listing of work requirements. Individuals may perform other duties as assigned including work in other functional areas to cover absences or relief, to equalize peak work periods or otherwise balance the workload.