USA Quality Assurance Lead III Scientific at Adecco USA

Adecco Healthcare & Life Sciences is hiring a contract Quality Assurance Lead III for our Pharmaceutical partner in Waltham, MA.

The anticipated wage for this position is $81- $82.50 hourly. 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:

• Reviews and approves Master Manufacturing Records, Stability Protocols and Reports, Sampling plans, and associated manufacturing documents for the timely initiation of GMP manufacturing activities.

• Provides 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.

• Reviews and Approves Analytical related documents such as Test Methods, Test Method Transfer Plans and Assessments.

• Issue/Review documentation, i.e. Deviations, CAPAs, OOS etc., as they occur.

• Write, revise and perform QA review and approval on SOPs, forms, WI, and other document types.

• Provides iShift support for GMID and BOM approval.

• Support of data analysis and metrics for Quality Council, KPls, and other reportable forums may be requested.

• Assume additional responsibilities as assigned.

Competencies/ Requirements for position

Qualifications/ Education & work experience

• 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: $81.00 to $82.50 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

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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