• Job Type:Contract

Posted 3 days ago

Shift Schedule: Monday through Friday - 1st shift

Job Description:

Hybrid role- Minimum 50% onsite and some activities can be done remote and other activities must be done onsitecontractor must be able to come onsite when needed.

Job Description:

• Strong background in Validation, Engineering, QA Computer System Engineer, or QA Engineering.

• 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 approve 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.

• Preferred some cell banking or project management experience.

• Preferred AIQ (Analytical Instruments qualification)/ Quality Control(QC) qualification experience

• This position will regularly interact with: Reporting Senior Manager.

• Sometimes will interact with departments listed below: Quality Control, Manufacturing Operations, Manufacturing Engineering, Manufacturing Science and Technology (MS&T), Validation, Site Engineering, and Digital Plant.

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.

• Greater than 12 years of relevant experience in a GMP, GCP, or GXP with at least

• 10 years focused on product quality. Preferred Active member of ASQ or ISPE.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

• Knowledge of electronic systems including any of the following: SAP, LIMS, Track Wise, 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

About ASK: ASK Consulting is an award-winning technology and professional services recruiting firm servicing Fortune 500 organizations nationally. With 5 nationwide offices, two global delivery centers, and employees in 42 states-ASK Consulting connects people with amazing opportunities

ASK Consulting is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all associates.