What are the responsibilities and job description for the QA Specialist - Records position at Global Technical Talent and Careers?
Primary Job Title
QA Specialist - Records (DHR)
Location
Scarborough, ME, US
Onsite Flexibility
Onsite
Contract Details
Position Type: Contract
Start: As Soon As Possible
Shift: 8 AM - 04:30 PM
Job Summary
The Quality Assurance Specialist II position is within our Infectious Disease Business Unit, located in 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.
Key Responsibilities
Quality System Management:
Review production batch records (DHRs) for accuracy and completeness to approve intermediate products for use in production. Review finished goods batch records. Report deviations in these records and ensure they have been addressed and resolved before issuing approval.
Conduct spot-checks, 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, 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
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 labelling
Labeling Process Administration:
Provide proofreading of product labeling before team review and approval
Initiate, execute, and implement label changes in coordination with interdepartmental and external stakeholders
Change Control Execution:
Assist with the implementation of product changes, in conjunction with project leads
Manage assigned Design Change projects (typically associated with product labeling)
Other duties may be assigned
Education Requirements
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
Required Experience
Minimum three years in a Quality Assurance role for manufacturing
Preferred Skills
3 years of prior experience in a Quality Assurance role or similar support role in the medical device industry
Required Skills
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 the 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 groups of customers or employees of the organization
Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form
Ability to apply mathematical concepts such as fractions, percentages, ratios, and proportions to practical situations
Attention to detail
Benefit:
Medical, Vision, and Dental Insurance Plans
401k Retirement Fund
About the Company:
Global Healthcare Innovator
We're a leading healthcare company dedicated to improving lives worldwide. Our diverse portfolio includes medical devices, diagnostics, nutrition products, and branded generics. We're committed to developing groundbreaking technologies that address critical healthcare challenges and empower people to live healthier lives.
Join our team and:
Work on cutting-edge projects
Contribute to global healthcare advancements
Experience diverse cultures and geographies
Discover a rewarding career with a company that cares.
About GTT
GTT is a minority-owned staffing firm and a subsidiary of Chenega Corporation, a Native American-owned company in Alaska. As a Native American-owned, economically disadvantaged corporation, we highly value diverse and inclusive workplaces. Our clients are Fortune 500 banking, insurance, financial services, and technology companies, along with some of the nation’s largest life sciences, biotech, utility, and retail companies across the US and Canada. We look forward to helping you land your next great career opportunity!
Job Number
26-02998
Hashtags
#gttic #LI-GTT #LI-Onsite
QA Specialist - Records (DHR)
Location
Scarborough, ME, US
Onsite Flexibility
Onsite
Contract Details
Position Type: Contract
Start: As Soon As Possible
Shift: 8 AM - 04:30 PM
Job Summary
The Quality Assurance Specialist II position is within our Infectious Disease Business Unit, located in 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.
Key Responsibilities
Quality System Management:
Review production batch records (DHRs) for accuracy and completeness to approve intermediate products for use in production. Review finished goods batch records. Report deviations in these records and ensure they have been addressed and resolved before issuing approval.
Conduct spot-checks, 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, 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
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 labelling
Labeling Process Administration:
Provide proofreading of product labeling before team review and approval
Initiate, execute, and implement label changes in coordination with interdepartmental and external stakeholders
Change Control Execution:
Assist with the implementation of product changes, in conjunction with project leads
Manage assigned Design Change projects (typically associated with product labeling)
Other duties may be assigned
Education Requirements
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
Required Experience
Minimum three years in a Quality Assurance role for manufacturing
Preferred Skills
3 years of prior experience in a Quality Assurance role or similar support role in the medical device industry
Required Skills
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 the 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 groups of customers or employees of the organization
Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form
Ability to apply mathematical concepts such as fractions, percentages, ratios, and proportions to practical situations
Attention to detail
Benefit:
Medical, Vision, and Dental Insurance Plans
401k Retirement Fund
About the Company:
Global Healthcare Innovator
We're a leading healthcare company dedicated to improving lives worldwide. Our diverse portfolio includes medical devices, diagnostics, nutrition products, and branded generics. We're committed to developing groundbreaking technologies that address critical healthcare challenges and empower people to live healthier lives.
Join our team and:
Work on cutting-edge projects
Contribute to global healthcare advancements
Experience diverse cultures and geographies
Discover a rewarding career with a company that cares.
About GTT
GTT is a minority-owned staffing firm and a subsidiary of Chenega Corporation, a Native American-owned company in Alaska. As a Native American-owned, economically disadvantaged corporation, we highly value diverse and inclusive workplaces. Our clients are Fortune 500 banking, insurance, financial services, and technology companies, along with some of the nation’s largest life sciences, biotech, utility, and retail companies across the US and Canada. We look forward to helping you land your next great career opportunity!
Job Number
26-02998
Hashtags
#gttic #LI-GTT #LI-Onsite