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Job Title: QA Lead Technical Operations

Compensation: $60 - $65 hourly

Schedule: M – F 1st Shift

Type: Contract, Potential for extension or conversion to permanent

Responsibilities

+ Provides Quality Assurance (QA) support to Devens Site and reporting Manger through quality review and approval of Investigations and Corrective Actions.

+ Decision making of non-conformance through a deep understanding of Quality Systems Regulatory expectations

+ Reviews and approves Quality, Quality Control, Validation and Automation related documents

+ Review and approves Standard Operating Procedures (SOPs).

+ Review and approval of Validation related documentation such as risk assessments, protocols and test scripts and summary reports.

+ Review and approval of change proposals as well as associated deliverables, ensuring the change deliverables meet external regulatory and internal WWQC guidelines and requirements.

+ Ability to coach across different departments within the subject matter of Investigations, CAPAs, general risk assessments and Validation.

+ Ability to self-manage and prioritize work across multiple competing deliverables.

+ Able to interpret complicated data and make sound decisions, Independently

This position will regularly interact with:

Reporting Manager

Sometimes will interact with departments listed below:

Quality Control

Manufacturing Operations

Manufacturing Engineering

Manufacturing Science and Technology (MS&T)

Validation

Site Engineering

Digital Plant

Education, Experience, and Qualifications:

+ Knowledge of science generally attained through studies resulting in a B.S; in Biological science, Engineering, biochemistry, or related discipline, or its equivalent is preferred.

+ Advanced Level of relevant experience in a GMP, GCP, or GXP with at least 8 years focused on product quality. Preferred Active member of ASQ or ISPE.

+ Prior experience of QC equipment Qualification and some project management experience

+ Knowledge of biotech, bulk drug substance or finished product manufacturing, medical device analytical testing is highly desirable.

+ Extensive knowledge of US and EU cGMP regulations and guidance and GAMP 5.

+ Knowledge of electronic systems including any of the following: SAP, LIMS, TrackWise, Veeva Vault and electronic or paper-based batch records desirable.

+ Excellent Technical writing and oral communication skills are required.

+ Background in problem solving

+ Knowledge of Data integrity principles

+ Proven attention to details

+ Comfortable working in an FDA regulated environment.

System One, and its subsidiaries including Joulé, ALTA IT Services, and Mountain Ltd., are leaders in delivering outsourced services and workforce solutions across North America. We help clients get work done more efficiently and economically, without compromising quality. System One not only serves as a valued partner for our clients, but we offer eligible employees health and welfare benefits coverage options including medical, dental, vision, spending accounts, life insurance, voluntary plans, as well as participation in a 401(k) plan.

System One is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, age, national origin, disability, family care or medical leave status, genetic information, veteran status, marital status, or any other characteristic protected by applicable federal, state, or local law.

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Ref: #558-Scientific

System One, and its subsidiaries including Joulé, ALTA IT Services, CM Access, TPGS, and MOUNTAIN, LTD., are leaders in delivering workforce solutions and integrated services across North America. We help clients get work done more efficiently and economically, without compromising quality. System One not only serves as a valued partner for our clients, but we offer eligible full-time employees health and welfare benefits coverage options including medical, dental, vision, spending accounts, life insurance, voluntary plans, as well as participation in a 401(k) plan.

System One is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, age, national origin, disability, family care or medical leave status, genetic information, veteran status, marital status, or any other characteristic protected by applicable federal, state, or local law.