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Job Title: Manufacturing Quality AssociateOur 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. Duties and Responsibilities:
You will 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. Your expertise will help in identifying deviations from established standards, in the manufacturing of clinical and commercial batches. You will make sure that product and process documents match the specifications based on established sampling and statistical process control procedures. In the relevant cases you will approve minor investigations and participate in minor change control activities to ensure compliance to procedures/GMPs.
As a QA Associate, your focus on the job will contribute to achieving project tasks and goals. Through your domain knowledge and commitment, you will create a collaborative teaming environment for your colleagues.
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.
Requirements:
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.
1-2 years of related pharmaceutical 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
Work EnvironmentM-F 2nd shift: 3pm-12am. The individual will train on the 1st shift for approximately 2 months until signed off to go to shift. The role is within a pharmaceutical manufacturing environment, producing commercial and clinical stage products. Candidates need to be available and prepared to be on the manufacturing floor with gowning required. Training schedule: M-F 8am-5pm.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.
