The Quality Engineering Specialist will support the necessary activities required for initiating, tracking and completing required project change control, documentation and various team level deliverables. Oversight, communication and accountability for these activities is critical to deliver items on schedule as required for project success.
Candidates will be leading issue resolution, tracking approvals within each part of the process, following up with teams on their timelines, pushing for approval completion, and overall assistance to teams in terms of tracking to full completion.
Position will involve driving documentation processes to keep them on track to meet deadlines.
Occasional data/write ups; meetings; record tracking.
Hours of Operations:
Typically, 7:30 am – 5:00 pm, Monday – Friday.
Project Areas Supported:
Equipment Prep and Aseptic Filling
Packaging and Warehousing
Sampling, Testing and Facility Shutdown
Team Support and Responsibilities Include:
Document Change Control Tracking, Follow Up and Approvals
Batch Record Tracking
Validation Support and Approvals
Managing hardcopy document collections (Project Development Related)
Use of computer applications to build tracking systems and communicate needs/status
Generate and/or review/approve project related validation, change control or other documentation
Participate in meetings to understand requirements and drive timely completion of team deliverables
Provide support to Pharmaceutical colleague PM assigned to project sub-team
Proficiency with Excel spreadsheets and able to document and organize data when requested
Create reports, tracks and communicates status of team deliverables to Key Stakeholders
System Interface (SAP, QTS, PDOCs, etc.)
Immediately escalate issues with potential project timeline impact
Manage the completion of weekly work targets and report weekly status of
progress, issues and risks to project management
Generate and/or review/approve various documentation and project deliverables
Effectively leads/facilitates/participates/completes cross-functional team
Project team, site leadership, project managers
Education & Experience
Some college level education preferred and prefer 2-3 years' industry experience (prefer corporate type environment)
Familiar with Microsoft Office (Excel, Word, PowerPoint - spreadsheets/data review) required.
Must be DRIVEN! Candidate should be comfortably actively leading + taking charge to ensure accuracy and time efficiency with deadlines.
Strict adherence to the onsite safety regulations and CDC guidelines.
Strong written and oral communication skills.
Pharmaceutical industry experience
Please submit your resume for consideration. Once submitted, feel free to contact Caitie at 646-415-8355 for additional information.
5 months/Potential Extension
About Hired By Matrix
Hired by Matrix, Inc. founded in 1986, is a certified Woman-Owned Business Enterprise (WBE) dedicated to providing the highest quality of job opportunities to our candidates and staffing services to our clients. We are a full service staffing firm with experience recruiting and delivering for IT, Accounting & Finance, Administrative & Clerical, Clinical & Scientific, and Marketing disciplines. Our long history in the staffing industry and dedication to excellence are the key differentiators that have fueled our success for over 30 years.
Hired by Matrix offers our contract professionals competitive salaries, benefits after 60 days and a 401k option after one year.
Equal Opportunity Employer
- CEO Sharon Olzerowicz serves on the WBENC Board and is a long-standing member of the Forum Governing Group.
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