Quality Associate

Description

Our client a global pharma manufacturer is seeking a Manufacturing Quality Associate to evaluate and review manufacturing activities (incoming material release, batch release, investigations, change controls, other activities as needed) in support of clinical and commercial batch production.

• Demonstrate sufficient depth of knowledge within your own work area to perform hands-on routine QA tasks.

• Exercise judgement in resolving level appropriate quality issues related to product manufacture and testing with guidance and coaching.

• Contribute to Quality Assurance activities by undertaking a variety of level appropriate assignments. You will perform end to end assignments within Manufacturing Quality Assurance. The assignments include incoming material review/release, batch record review (to include in-process batch record review/QA-on-the-floor activities), minor investigation review/approval and minor change control activities to assurance compliance with regulatory standards and regulatory filing.

• Contribute to the completion of projects, manage own time to meet agreed targets and develop plans for work activities on own projects within a team.

• Accurately communicate supply, operational needs or Quality Operations (QO) perspectives and escalate issues with potential market or stability impact.

• Maintain inspection readiness, support inspections from regulatory and improve quality assurance systems.

• Assist and support the manufacturing staff in detecting and solving compliance errors in real time during manufacturing operations.

• Use established QA procedures and methodologies to propose solutions for straight forward problems with guidance and coaching.

Skills

Quality assurance, batch record review, batch record release, Audit, Capa, Batch record, Sop, Compliance, Document control, GMP

Top Skills Details

Experience within pharma GMP handling batch record review and release

Additional Skills & Qualifications:

Bachelor's Degree with 0-2 years of relevant experience, Associates' Degree with 4+ years of relevant experience OR High School Diploma or Equivalent with 6+ years of relevant experience.

• Experience in Quality administered systems.

• Sound knowledge of current Good Manufacturing Practices.

• Ability to work in a team environment within own team and interdepartmental teams.

• Good written and oral communication skills.

• Willing to lead by example and jump right in, desire to get to root cause, collaborative and active listener.

• Effectively manages stressful situations, able to focus on task regardless of circumstances and stress induced pressure.

• Good collaboration, relationship management and interpersonal skills.

• Field of study in Biology, Chemistry, Engineering, or related Technical Physical Science.

• Experience at a manufacturing site.

• Experience of writing and managing deviations.

• Experience in production batch record review and change control management.

• Experience with SAP, LIMS, QTS

BENEFITS

• Medical, dental, and vision insurance

• Six paid legal holidays: New Year's Day, Memorial Day, July Fourth, Labor Day,

• Thanksgiving Day, and Christmas Day

• Paid time off

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

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 ~~~ (~~~) for other accommodation options.