Akkodis
Hybrid Pharmaceutical Quality Assurance Associate II
Akkodis, Waltham, Massachusetts, United States, 02254
Akkodis is seeking a Hybrid Pharmaceutical Quality Assurance Associate II for a 12-month contract job with a client in Waltham, MA. You will review and approve Master Manufacturing Records, Stability Protocols and Reports, Sampling plans, and associated manufacturing documents for the timely initiation of GMP manufacturing activities. The schedule is Monday through Friday 8:00 am - 4:00 pm or 9:00 am - 5:00 pm (some flexibility with hours). Hybrid role.
Rate Range: $45.00/hour to $48.00/hour; The rate may be negotiable based on experience, education, geographic location, and other factors.
Hybrid Pharmaceutical Quality Assurance Associate II job responsibilities include:
• Perform QA review of Executed Batch Records. Quality Records, i.e. Deviations, CAPAs, OOS etc., as they occur, 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 and assist with internal and external audits.
• Support of data analysis and metrics for Quality Council, KPls, and other reportable forums may be requested.
• Will be reviewing docs in Veeva.
Desired Qualifications:
• Bachelors Degree with five years of experience, or no degree and eight years of experience in clinical or pharmaceutical manufacturing
• Minimum five 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, Project and Veeva
• Experience with batch record review (master and executed)
• Must be flexible with change in priorities, need to shift gears quickly
If you are interested in this role, then please click APPLY NOW. For other opportunities available at Akkodis go to www.akkodis.com.
Equal Opportunity Employer/Veterans/Disabled
To read our Candidate Privacy Information Statement, which explains how we will use your information, please visit https://www.akkodis.com/en/privacy-policy.
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
Pay Details:
$45.00 to $48.00 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.akkodis.com/en/us/candidate-privacy-policy
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
Rate Range: $45.00/hour to $48.00/hour; The rate may be negotiable based on experience, education, geographic location, and other factors.
Hybrid Pharmaceutical Quality Assurance Associate II job responsibilities include:
• Perform QA review of Executed Batch Records. Quality Records, i.e. Deviations, CAPAs, OOS etc., as they occur, 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 and assist with internal and external audits.
• Support of data analysis and metrics for Quality Council, KPls, and other reportable forums may be requested.
• Will be reviewing docs in Veeva.
Desired Qualifications:
• Bachelors Degree with five years of experience, or no degree and eight years of experience in clinical or pharmaceutical manufacturing
• Minimum five 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, Project and Veeva
• Experience with batch record review (master and executed)
• Must be flexible with change in priorities, need to shift gears quickly
If you are interested in this role, then please click APPLY NOW. For other opportunities available at Akkodis go to www.akkodis.com.
Equal Opportunity Employer/Veterans/Disabled
To read our Candidate Privacy Information Statement, which explains how we will use your information, please visit https://www.akkodis.com/en/privacy-policy.
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
Pay Details:
$45.00 to $48.00 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.akkodis.com/en/us/candidate-privacy-policy
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