Lead QA Technical Operations

Support Devens site through review and approval of technical transfer documentation, risk assessments and change controls. Assure the quality of products to be manufactured are in compliance with all applicable regulations and guidelines.

• Supports and provides quality oversight to technical transfer sub-teams and the review and approval of tech transfer documentation, including facility fit reports, gap assessments, risk assessments, and protocols.
• Supports risk assessments for Biologics, Viral Vectors, mRNAs, Facility Controls, Cross-contamination controls. Highlights key risks and uses sound judgment to ensure that risk identification, documentation and communication is maintained.
• Provides expertise on facility controls to a team of QA Technical Operations that supports Technical Transfer.
• Assures consistent, effective use of the site change control system for all change requests. Ensures supporting documentation and change deliverables meet external regulatory and internal Global BMS guidelines and requirements.
• Provides quality support and oversight for Manufacturing Science and Technology and Validation protocols and reports, in support of equipment qualification, cleaning validation.
• Makes sound decisions by exercising judgment within generally defined practices and policies and applies appropriate notification to management as appropriate.
• May provide guidance to less experienced staff.
• Participates in routine tech transfer meetings as a quality representative.
• Supports risk assessment and gap assessments.

• Knowledge of biotech bulk and finished product manufacturing, analytical testing is highly desirable.
• Knowledge of facility and cross-contamination controls in a biologics facility.
• Expertise in operational controls for manufacture of different modality products in a facility (e.g. Biologics and Viral Vectors).
• Extensive knowledge of US and EU cGMP regulations and guidance. Knowledge of Annex 1 a plus.
• Knowledge of Quality Risk Management principles required.
• Knowledge of electronic systems including any of the following:
  Infinity (Veeva Vault).
• Experience working in a team-based environment with a diverse group of people.
• Excellent writing and oral communication skills are required.

• Knowledge of science generally attained through studies resulting in a B.S. in science, engineering, biochemistry or related discipline.
• Need 8 of years of relevant experience in a regulated environment with at least 4 years focused on product quality.

• Work in a cGMP manufacturing environment following techniques which require one to maintain a high attention to detail.

• Take action, final decision, recommend Exercises judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions.
• Supervision Received Receives supervision and identifies and reports any discrepancies from normal practices or procedures to management, recommending and implementing corrective actions.
• Reports to the manager of QA Technical Operations. Receives assignments from Management.
• Supervision Exercised.

Mon - Fri (normal business hours)

This posting is for a contract assignment with ASK Staffing DBA ASK Consulting to provide services to Bristol Myer-Squibb
.

The starting hourly compensation for this assignment is the following range ($63- $66.39/hr). While the final, individual compensation and any available benefits will be determined by your employer of record ASK Staffing, Inc (and not BMS), factors that will be included in making the final determination may include the characteristics of the assignment, such as demonstrated experience, required skill, and the geographic location where the job is performed.

The starting hourly compensation may be subject to change.

ASK Consulting is an award-winning, woman-owned staffing and recruitment solutions provider with over three decades of industry experience. We specialize in connecting businesses of all sizes?across IT, healthcare, engineering, finance, and more?with top-tier professionals. Backed by a global network and personalized service approach, our team is dedicated to building meaningful partnerships that drive organizational success and empower job seekers to excel in their careers.

ASK Consulting provides comprehensive, ACA-compliant health coverage, along with dental, vision, Short- and Long-Term disability for eligible employees. We also offer commuter benefits, a 401(k) plan with no matching, and a referral bonus program. In addition, ASK Consulting offers unpaid leave and paid sick leave as required by law.

ASK Consulting is an equal opportunity employer and does not discriminate against employees or applicants based on race, religion, color, sex, national origin, age, sexual orientation, gender identity, genetic information, disability, veteran status, or any other…