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Job Requirements of QA Specialist II:
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Employment Type:
Full-Time
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Location:
Scarborough, ME (Onsite)
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QA Specialist II
Please Contact: To discuss this amazing opportunity, reach out to our Talent Acquisition Specialist Ram Sasane at email address can be reached on #
We have Contract role QA Specialist for our client at Scarborough. ME. Please let me know if you or any of your friends would be interested in this position.
Position Details:
QA Specialist -Scarborough. ME
Location : Scarborough. ME 04074
Project Duration :6+ Months of contract
Payrate: : $29/hr. on W2
Description:
The position of Quality Assurance Specialist II is within our Infectious Disease Business Unit located at Scarborough, Maine.
In this role you will, under minimal direction, perform a wide variety of activities to support the Quality Management System.
This job description will be reviewed periodically and is subject to change by management.
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RESPONSIBILITIES:
The following activities may be assigned as applicable:
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Quality System Management
Review production batch records (DHRs) for accuracy and completeness in order to approve intermediate products for use in production.
Review finished goods batch records.
Report deviations in these records and assure they have been addressed and resolved prior to issuing approval.
Conduct spot-check inspections/audits of production operations
Participate in the internal audit program
Write, review and approve Standard Operating Procedures (SOPs) as necessary
Assist with and may write validations/test protocols as necessary
Assist in testing of complaint samples and stability samples and report results out of acceptance limits
Provide backup to other Quality Specialists
Initiate and author Deviations and Quality Incidents (QI)
May administer the calibration program
May administer the document control system
May administer the Deviation, Quality Incident and CAPA programs
May organize the long-term stability program and be responsible for administering the sample retention program
May administer the Quality Records program and assist and act as backup to the Document Control Specialist II
Train new and current Quality Assurance Technicians and Specialists as needed
Other duties may be assigned.
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Change Control Management
Change Management Documentation
Assignment of Design History File numbers
Compile and maintain quality system records associated with design change projects, including project definitions, first-lot-to-stock, product qualification records, etc.
Ensure records for design change projects are complete and align with SOPs
Manage organization, storage, and archival of documentation and records associated with design changes and labeling
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Labeling Process Administration:
Provide proofreading of product labeling prior to team review and approval
Initiate, execute and implement label changes in coordination with interdepartmental and external stakeholders
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Change Control Execution:
Assist with implementation of product changes, in conjunction with project leads
Manage assigned Design Change projects (typically associated with product labeling)
Other duties may be assigned.
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BASIC QUALIFICATIONS | EDUCATION:
Bachelor's Degree in Chemistry, Biology, Life Science, or other related technical field in a scientific or technical area or the equivalent combination of education and experience
Minimum three years in a Quality Assurance role for manufacturing.
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PREFERRED QUALIFICATIONS:
3+ years prior experience in a Quality Assurance role or similar support role in the medical device industry
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COMPETENCIES:
Ability to follow procedures and accurately document results
Knowledge of site software for inventory management, document control and quality incident tracking
Good working knowledge of Excel and Microsoft Word software
Ability to understand manufacturing processes of Company products and ability to recognize deviations from approved documented procedures
Ability to read and interpret documents such as safety rules, operating and maintenance instructions, and procedure manuals
Ability to write routine reports and correspondence
Ability to speak effectively before
To discuss this amazing opportunity, reach out to our Talent Acquisition Specialist Ram Sasane at email address can be reached on #