Description:

This role is 100 Onsite

Work Schedule: Mon - Fri 07:00 AM - 03:30 PM EST

Holidays required as needed

JOB SUMMARY

The Contractor Field QA Specialist is responsible for quality activities for the Single Use Facility in accordance with company policies standards procedures and Global cGMP. Functional responsibilities include ensuring manufacturing compliance with applicable procedures and batch records providing real time review of manufacturing batch record documentation and logbooks and working with operations to resolve manufacturing issues. The Contractor Field QA Specialist role is stationed in Devens MA and reports to the Sr. Manager of QA Operations for the Devens SUF.

JOB RESPONSIBILITIES

• Perform QA on the floor activities.

• Ensure manufacturing compliance with applicable procedures and batch records.

• Perform real time review of manufacturing batch records.

• Review manufacturing shop floor documentation.

  EDUCATION REQUIREMENTS

• High School Degree required

• Relevant college or university degree preferred.

• Minimum 4 years relevant work experience with experience in a Quality Assurance role.

  QUALIFICATIONS REQUIRED

• Equivalent combination of education and experience acceptable.

• Must be action-oriented and skilled in decision-making building relationships problem solving conflict management planning and organizing resource allocation coaching others and analytical thinking.

• Understands continuous improvement and improves efficiency and productivity within the group or project.

• Builds relationships internally within and with cross functional teams.

• Must have sound knowledge and experience in FDA regulated cGMP warehousing Quality and compliance environments. Prefer to also have knowledge of GMP Manufacturing operations and processes.

• Directs quality initiatives that accomplish continuous improvement and enhance site quality system efficiencies.

• Routinely recognizes and resolves Quality issues Informs management of proposed solutions. Seeks management guidance on complex issues.

• Able to recognize conflict and notify management with proposed recommendations for resolution.

• Must possess an independent mindset. Work is self-directed.

• Requires moderate direction to complete more complex tasks completes routine tasks with little or no supervision.

• Confident in making decisions for non-routine issues.

• Develops and revises procedures.

• Intermediate to advanced ability to interpret results and situations and articulate recommendations for resolution.

• Able to prepare written communications and communicate problems to management with clarity and accuracy.

• Able to effectively multi-task.

• Knowledge of US and global cGMP requirements.

  Must have strong authorship and ability to critically review investigations interpret results and generate technical conclusions consistent with Quality risk management principles.

• Must be skilled in planning and organizing decision-making and building relationships.

• Knowledge of quality processes including material disposition change control product complaints deviations investigations and CAPA management.

• Able to effectively multi-task.

• Must have strong authorship and ability to critically review investigations interpret results and generate technical conclusions consistent with Quality Risk Management principles.

• Must be skilled in planning and organizing decision-making and building relationships.

• Knowledge of quality processes change control product complaints deviations investigations and CAPA management.

If interested, please reach out directly to Lindsee Allienello at lallienello @ actalentservices.com.

About Actalent

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.

Diversity, Equity & Inclusion

At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through:

• Hiring diverse talent

• Maintaining an inclusive environment through persistent self-reflection

• Building a culture of care, engagement, and recognition with clear outcomes

• Ensuring growth opportunities for our people

The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email actalentaccommodation@actalentservices.com (%20actalentaccommodation@actalentservices.com) for other accommodation options.