QA Lead Technical Operations

QA Lead Technical Operations, Projects

Onsite, Devens location

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

Job Description/ 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

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.

Contractor must be able to come onsite Monday through Friday - 1st shift