16 Quality AIQ Specialist Jobs in Lexington, MA
SORT BY
A
S
L
L
R
R
S
R
S
L
R
L
S
U
K
S
Sunrise Systems is Hiring a Quality AIQ Specialist Near Lexington, MA
Title: Quality AIQ Specialist
Location: Lexington, MA
Duration: 12 months on Contract
Recommended experience: 4-7 years Intermediate level, and 8 for Senior levelJob SummaryPrimary duties of the position are focused around the qualification of QC analytical equipment.
Primary activities would generally include but not limited to gap assessment and remediation, equipment classification and release, URS generation, design qualification, computerized system categorization, IOQ protocol and reports, equipment decommissioning, relocation and requalification activities.
Discretion/Latitude
Erroneous decisions or failure to achieve objectives would normally have a serious effect upon the administration of the organization.
Specific QC Focus Area: Technical Support:
Job Function And Description
Location: Lexington, MA
Duration: 12 months on Contract
Recommended experience: 4-7 years Intermediate level, and 8 for Senior levelJob SummaryPrimary duties of the position are focused around the qualification of QC analytical equipment.
Primary activities would generally include but not limited to gap assessment and remediation, equipment classification and release, URS generation, design qualification, computerized system categorization, IOQ protocol and reports, equipment decommissioning, relocation and requalification activities.
Discretion/Latitude
- Work is performed under general direction with little to no supervision. Participates in determining objectives of assignment.
- Plan schedules and arranges own activities in accomplishing objectives.
- Work may be reviewed upon completion for adequacy in meeting objectives.
Erroneous decisions or failure to achieve objectives would normally have a serious effect upon the administration of the organization.
Specific QC Focus Area: Technical Support:
- Support QC analytical instrumentation/equipment validation life cycle and executing these activities under GMP compliance.
- Support QC lab renovation/equipment relocation and equipment qualification activities.
- Project Manage the QC Equipment Validation projects.
- Document analytical equipment qualifications in written reports and procedures, i.e. URS, Trace Matrix, System Categorization, DQ, IQ/OQ/PQ, and decommissioning documents.
- Support QC analytical instrument/equipment decommissioning.
- Determine max loads for temperature mapping of QC environmental chambers.
- Identify the need for process improvements and assess/drive new analytical technologies or processes that would improve throughput and time savings.
Job Function And Description
- 75% Develop and execute primary duties.
- 10% Involvement in other QC activities as required; involvement on departmental and cross-functional teams as required on various initiatives and/or quality events
- 5% Identify the need for process improvements and assess/drive new analytical technologies or processes that would improve throughput and time savings.
- 5% Work within QC to maintain an efficient compliant laboratory (including but not limited to instruments, documentation, SOPs, etc).
- 5% Interact with and provide support for interdepartmental customers as resource for data and analytical expertise and to address testing, operational or compliance related issues.
- Typically requires a bachelor s degree and a minimum of 5 year of related experience.
- Additional Specific Experience: Excellent communication, interpersonal and organizational skills.
- Ability to work well both independently and in a team environment.
- Ability to prioritize work and multitask. Conducts work in compliance with cGMPs, safety, and regulatory requirements
- Knowledge: Complete understanding and application of principles, concepts, practices, and standards of instrument qualification. Full knowledge of industry GMP and validation practices. Position requires critical thinking.
- MS Office, ValGenesis, TrackWise, EDMS, compliance, and a strong science and/or validation understanding
- Some travel may be expected; although not routine.
- Travel between sites may be required.
Job Summary
JOB TYPE
Contractor
SALARY
$100k-126k (estimate)
POST DATE
06/08/2024
EXPIRATION DATE
07/26/2024
WEBSITE
sunrisesystems.com
HEADQUARTERS
PEMBROKE, MA
SIZE
50 - 100
TYPE
Private
CEO
HENRY C APPLETON
REVENUE
$5M - $10M
Related Companies
Show more
Similar Jobs
Popular Articles
Top 10 Things to Avoid Putting on a Job Application
Read Article
How to Describe Your Education in a Resume
Read Article
How to Write a Memorable Cover Letter in 5 Ways
Read Article
4 Personal Finance Tips to Make During Job Transition
Read Article
4 Best Camera Setups for Interview
Read Article
Keeping a Job Search Journal: 9 Types of Journaling You Can Do
Read Article
