QA Lead Technical Operations- Pharma (Onsite - Devens, MA)

QA Lead Technical Operations- Pharma (Onsite Devens, MA)

We are seeking a QA Lead Technical Operations- Pharma for a global pharmaceutical client. You will provide Quality Assurance (QA) support to Devens Site and the reporting Manager through quality review and approval of Investigations and Corrective Actions.

This is a 40-hour per-week, 6-month contract (extensions possible), 100% onsite role in Devens, MA. Work Schedule: Mon - Fri, First shift (8:30AM - 5PM)

This is a W2 role as a Stage 4 Solutions employee. Health benefits and a 401K are offered.

Responsibilities:

• 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
  
  

Requirements:

• 8+ years of experience in a GMP, GCP, or GXP focused on product quality, preferred Active member of ASQ or ISPE.

• Prior experience of QC equipment Qualification and some project management

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

• Technical Writer and Investigations/Deviation experience preferred.

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

• Knowledge of Data integrity principles

• Knowledge of biotech, bulk drug substance or finished product manufacturing, medical device analytical testing is highly desirable. Comfortable working in an FDA regulated environment

• B.S Degree

Please submit your resume to our network at (please apply to the QA Lead Technical Operations- Pharma (Onsite Devens, MA) role).

Please feel free to forward this project opening to others who may be interested.

Stage 4 Solutions is an equal-opportunity employer. We celebrate diversity and are committed to providing employees with an inclusive environment that is free of discrimination and harassment. All employment decisions are based on the job requirements and candidates' qualifications, without regard to race, color, religion/belief, national origin, gender identity, age, disability, marital status, genetic information, or other applicable legally protected characteristics.

Compensation: $60/hr. - $65/hr.

#LI-SW1