Adecco US, Inc.
Quality Assurance Associate
Adecco US, Inc., Waltham, Massachusetts, United States, 02254
Adecco is currently hiring a contract Quality Assurance Associate for our Pharmaceutical partner in Waltham, MA.
The anticipated hourly wage for this position is$45- $46.65. Hourly wage may depend upon experience, education, geographic location, and other factors.
Benefit offerings include medical, dental, vision, life insurance, short-term disability, additional voluntary benefits, EAP program, commuter benefits and 401K plan. Our program provides employees the flexibility to choose the type of coverage that meets their individual needs. Available paid leave may include Paid Sick Leave, where required by law; any other paid leave required by Federal, State, or local law; and Holiday pay upon meeting eligibility criteria.
Job Description:
· Review and approve Master Manufacturing Records, Stability Protocols and Reports, Sampling plans, and associated manufacturing documents for the timely initiation of GMP manufacturing activities.
· Perform QA review of Executed Batch Records.
· Perform QA review of Quality Records, i.e. Deviations, CAPAs, OOS etc., as they occur.
· Perform QA review and approval on SOPs, forms, WI, and other document types.
· Provide SAP support for GMID and BOM approval.
· Provide Quality oversight and Quality guidance to resolve compliance issues for lots of drug substance, bulk drug product, drug product and clinical materials for use in clinical trials.
· Ensure all requirements, stipulated in the CMO Quality Agreements, are being met.
· Review and Approve Analytical related documents such as Test Methods, Test Method Transfer Plans and Assessments, if needed.
· Participate in Quality Risk Assessments
· Assist with internal and external audits.
· Support of data analysis and metrics for Quality Council, KPls, and other reportable forums may be requested.
· Assume additional responsibilities as assigned.
Education/Requirements:
· Bachelor's and/or 8+ years of relevant experience
· Minimum 5 years of experience in Quality
· Working knowledge and ability to apply Quality principles and cGMPs in conformance to standards, preferably gained from working in a manufacturing, QA or QC environment.
· Demonstrated ability to interact and communicate effectively, both written and verbal, with peers, management, auditors, and consultants.
· Must have excellent attention to detail, project and time management skills, and the ability to
· manage multiple priorities with aggressive timelines.
· Preferred experience with outsourced manufacturing and testing operations
· Working knowledge of MS Office products including Word, Excel, Outlook, PowerPoint, and Project.
Pay Details: $45.00 to $46.65 per hour
Benefit offerings available for our associates include medical, dental, vision, life insurance, short-term disability, additional voluntary benefits, EAP program, commuter benefits and a 401K plan. Our benefit offerings provide employees the flexibility to choose the type of coverage that meets their individual needs. In addition, our associates may be eligible for paid leave including Paid Sick Leave or any other paid leave required by Federal, State, or local law, as well as Holiday pay where applicable.
Equal Opportunity Employer/Veterans/Disabled
To read our Candidate Privacy Information Statement, which explains how we will use your information, please navigate to https://www.adecco.com/en-us/candidate-privacy
The Company will consider qualified applicants with arrest and conviction records in accordance with federal, state, and local laws and/or security clearance requirements, including, as applicable:
The California Fair Chance Act
Los Angeles City Fair Chance Ordinance
Los Angeles County Fair Chance Ordinance for Employers
San Francisco Fair Chance Ordinance
The anticipated hourly wage for this position is$45- $46.65. Hourly wage may depend upon experience, education, geographic location, and other factors.
Benefit offerings include medical, dental, vision, life insurance, short-term disability, additional voluntary benefits, EAP program, commuter benefits and 401K plan. Our program provides employees the flexibility to choose the type of coverage that meets their individual needs. Available paid leave may include Paid Sick Leave, where required by law; any other paid leave required by Federal, State, or local law; and Holiday pay upon meeting eligibility criteria.
Job Description:
· Review and approve Master Manufacturing Records, Stability Protocols and Reports, Sampling plans, and associated manufacturing documents for the timely initiation of GMP manufacturing activities.
· Perform QA review of Executed Batch Records.
· Perform QA review of Quality Records, i.e. Deviations, CAPAs, OOS etc., as they occur.
· Perform QA review and approval on SOPs, forms, WI, and other document types.
· Provide SAP support for GMID and BOM approval.
· Provide Quality oversight and Quality guidance to resolve compliance issues for lots of drug substance, bulk drug product, drug product and clinical materials for use in clinical trials.
· Ensure all requirements, stipulated in the CMO Quality Agreements, are being met.
· Review and Approve Analytical related documents such as Test Methods, Test Method Transfer Plans and Assessments, if needed.
· Participate in Quality Risk Assessments
· Assist with internal and external audits.
· Support of data analysis and metrics for Quality Council, KPls, and other reportable forums may be requested.
· Assume additional responsibilities as assigned.
Education/Requirements:
· Bachelor's and/or 8+ years of relevant experience
· Minimum 5 years of experience in Quality
· Working knowledge and ability to apply Quality principles and cGMPs in conformance to standards, preferably gained from working in a manufacturing, QA or QC environment.
· Demonstrated ability to interact and communicate effectively, both written and verbal, with peers, management, auditors, and consultants.
· Must have excellent attention to detail, project and time management skills, and the ability to
· manage multiple priorities with aggressive timelines.
· Preferred experience with outsourced manufacturing and testing operations
· Working knowledge of MS Office products including Word, Excel, Outlook, PowerPoint, and Project.
Pay Details: $45.00 to $46.65 per hour
Benefit offerings available for our associates include medical, dental, vision, life insurance, short-term disability, additional voluntary benefits, EAP program, commuter benefits and a 401K plan. Our benefit offerings provide employees the flexibility to choose the type of coverage that meets their individual needs. In addition, our associates may be eligible for paid leave including Paid Sick Leave or any other paid leave required by Federal, State, or local law, as well as Holiday pay where applicable.
Equal Opportunity Employer/Veterans/Disabled
To read our Candidate Privacy Information Statement, which explains how we will use your information, please navigate to https://www.adecco.com/en-us/candidate-privacy
The Company will consider qualified applicants with arrest and conviction records in accordance with federal, state, and local laws and/or security clearance requirements, including, as applicable:
The California Fair Chance Act
Los Angeles City Fair Chance Ordinance
Los Angeles County Fair Chance Ordinance for Employers
San Francisco Fair Chance Ordinance