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QA lead technical operations(GMP and CAPA)

2 months ago

Devens, United States System One Full time

Job Title:(GMP & CAPA)QA lead technical operations

Location: Devens, MA

Hours/Schedule: Mon - Fri, First shift (8:30AM - 5PM)

Type: Contract

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, in a remote working environment

Able to interpret complicated data and make sound decisions, Independently

Requirements

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.

Benefits

System One offers eligible employees health and welfare benefits coverage options, including medical, dental, vision, spending accounts, life insurance, voluntary plans, and participation in a 401(k) plan.

#M3

System One, and its subsidiaries including Joul, 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.