Quality Assurance Specialist I/II - Quality Systems (Contract)

Location: Lynnwood,Washington,United States

QUALITY ASSURANCE SPECIALIST I/II - QUALITY SYSTEMS (CONTRACT)

POSITION SUMMARY

The Quality Systems Specialist is responsible for supporting records and document management activities for our Quality function. 

PRIMARY RESPONSIBILITIES

• Performs review, formatting, and routing of documents using electronic document management system.
• Verifies scanned records against physical originals. Verifies completeness of scanned records for archived materials.
• Packs and indexes boxes for offsite storage.
• Receives, indexes, and files Quality, Manufacturing, and other Scientific records submitted for archival.
• Supports administration of the electronic quality management system (MasterControl) including but not limited to user account management, workflow management, and library updates.
• Follows standard operation procedures (“SOPs”) governing their activities and maintains compliance requirements at all times.
• Supports inspections conducted by internal auditors and external agencies.
• Supports Quality Systems projects for system implementation and continuous improvement.
• Provides instruction and technical support in the use of electronic quality management system software and processes.
• Resolves “stuck” issues by ensuring timely issue escalation to Leadership and cross-functional teams: Applies learning from these events and leads the creation of new/updated systems, processes, programs to prevent similar situations in the future.
• Adheres to all applicable regulations and requirements including compliance with internal SOPs, GMP, Health and Safety, WISHA/OSHA, regulatory compliance, company policies, and employment-related laws and statutes.
• Successfully completes all mandatory Quality and Compliance training within required timeframes.
• This job description is not intended to be all-inclusive. Partners may be required to perform other related duties as required to meet the ongoing needs of the organization.

KNOWLEDGE, SKILLS, ABILITIES

Required:

• Familiarity with electronic records management, document management, or quality management software (EDMS/QMS/RIMS).
• Perform review, formatting, and routing of documents using electronic document management system.
• High attention to detail and ability to find errors or inconsistencies.
• Strong critical thinking, analytical, and problem-solving skills with the proven ability to formulate solutions to propel the organization forward.
• Strong, collaborative relationship management and interpersonal skills required to quickly gain confidence of stakeholders and team members.
• Possesses strong organizational and prioritization skills to maintain a high level of productivity and priority-setting in order to complete assignments on-time and on-budget.
• Excellent soft skills including a bias towards action, the ability and willingness to give and receive constructive feedback, is comfortable working within a diverse team and across multiple functions, exhibits a consistently constructive attitude, and is adaptable and at ease with handling unexpected change and challenges.
• Strong written and oral English communication skills are required for this highly collaborative role. Proven ability to make clear, effective, and persuasive presentations to audiences at various levels of expertise required. Skilled at leading effective meetings.
• Solid software skills essential including Word, Excel, Powerpoint, and Outlook; ability and willingness to quickly adopt other job-specific applications will be necessary.

Preferred:

• Knowledge of current Good Manufacturing Practices (“cGMP”) regulations and guidance documents pertaining to Documents, Training, and/or Records Management.
• Software application experience with Smartsheet, MS Project, and SharePoint.
• Project management experience or formal training.

EXPERIENCE & EDUCATION

Quality Assurance Specialist I

Required:

• High school diploma or GED required.
• 1+ plus years of experience in records management in a highly regulated environment or medical setting required.

Preferred:

• Associate, BA, BS or equivalent.
• Recent experience using and administering databases.
• Experience in healthcare, pharmaceutical, medical device, biotech, food manufacturing, environmental laboratory, or other regulated environment.

EXPERIENCE & EDUCATION

Quality Assurance Specialist II

Required:

• High sc