Waltham, MA, 02454, USA
6 days ago
USA Quality Assurance Associate III Scientific
Adecco Healthcare & Life Sciences is hiring a hybrid contract Quality Assurance Associate III for our Pharmaceutical partner in Waltham, MA. The anticipated hourly wage for this position is between $59 and $60.70. 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 Due to upcoming holidays and the manager is OOO the manager would like to select a candidate for Open to candidates willing to relocate at their own expense Final round interviews will be required onsite **Jon Summary:** · Reviews executed batch records and related documentation, resolves compliance issues and dispositions lots of drug substance, bulk drug product, drug product and clinical materials for use in clinical trials · Perform lot release Quality Review of manufacturing and quality control records to ensure compliance with specifications and regulations. · Ensure that all requirements, as stipulated in the appropriate QTA, have been met. · Issue/Review documentation, i.e. Deviations, CAPAs, OOS (out of spec) etc., as they occur. · Write and revise SOP, forms, WI, and any other document types · Assist with internal and external audits. · Support of data analysis and metrics for QMR, KPIs, and other reportable forums may be requested. · Assume additional responsibilities as assigned. **Must Have Experience:** · Bachelor’s and/or 8+ years of relevant experience · Minimum 5 years of experience in Quality Assurance (Prefer Lot release experiences) – must be specific to pharm industry · PHD may be considered overqualified · Issue/Review documentation, i.e. Deviations, CAPAs, OOS etc., as they occur. · Write and revise SOP, forms, WI, and any other document types · Assist with internal and external audits. · Support of data analysis and metrics for QMR, KPIs, and other reportable forums may be requested. · Working knowledge of MS Office products including Word, Excel, Outlook, PowerPoint, and Project. **Nice to Have Experience:** · investigation or product complaint experience · Preferred experience with outsourced manufacturing and testing operations **Pay Details:** $59.00 to $60.70 per day 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
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