QA lead technical operations

Devens, Massachusetts

Employer: ASK Staffing
Industry: 
Salary: $66.07 per hour
Job type: Full-Time
"All candidates must be directly contracted by ASK Consulting on their payroll and cannot be subcontracted. We are unable to provide sponsorship at this moment".

Job Title: QA lead technical operations

Location: Devens, MA 01434 (Remote)

Duration: 9 months

Pay rate: $66.07/hr. on w2

Job Description:

Responsibilities:
  • 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 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
  • Preferred some project management 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
  • 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 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.

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.
Created: 2024-05-04
Reference: 235033
Country: United States
State: Massachusetts
City: Devens

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