Job Title: QA Associate

Job Description

Collaborate with stakeholders to manage the Quality System. Recommend and implement changes to the existing quality system regarding nonconforming products, corrective/preventive actions, document control, quality control inspections and product release, internal audits, validations, and equipment calibration and maintenance programs.

ResponsibilitiesManage all activities involving quality assurance and compliance with applicable regulatory requirements.Handle regulatory submissions and ensure compliance with national and international regulations.Conduct audits, review and analyze data and documentation, manage the internal audit program, and support QMS-related activities.Host customer audits.Perform supplier audits and support the supplier audit program.Initiate, investigate, and complete corrective actions (CA) and participate in MRB meetings. Apply problem-solving tools and methods to coordinate or lead investigation teams.Participate in the management and execution of equipment, process, and software validation.Manage the equipment calibration and maintenance program.Provide directions for all aspects of testing related to manufacturing, including first article inspection, in-process release inspection, final QC release of finished goods, and document review.Ensure all inspections and procedures are properly completed and documented.Review all quality assessment results and determine whether to accept or reject manufactured products during the inspection process.Perform environmental monitoring of cleanrooms and analyze bioburden results. Provide solutions for microbial failures.Assist the department with continuous improvement initiatives or lean projects.Serve as the Quality Assurance representative on facility projects.Respond to customer complaints and collaborate with internal departments for resolution and preventative corrective actions.Essential Skills2-4 years of experience in a Quality role within a heavily regulated environment.Experience with ERP systems (e.g., SAP, Oracle, SyteLine).Proficiency in change control management and CAPA.Strong understanding of quality assurance, supplier quality, and medical devices.Additional Skills & QualificationsBachelor's degree in Engineering or a related field preferred.Experience in quality operations within a manufacturing environment, preferably in a similar industry, minimally in an ISO environment.Strong understanding of global pharmaceutical and biotechnology product regulations with proven experience with ISO 9001 and/or :2003 and 21 CFR Parts 210 and 211 and/or Part 820.Experience with technical documentation for complex activities in areas of the Quality System, including corrective actions, change control, quality audits, and validation of manufacturing processes or product development in a pharmaceutical or medical device environment.Proficient problem-solving skills through the use of continuous improvement tools; certification desired in ASQ, Green Belt, Lean, or equivalent.Proficiency in multiple quality systems including exception management, change control, document control, product release, etc., with strong decision-making skills utilizing risk management.Computer skills with ERP systems such as SyteLine, SAP, Oracle, etc.Work Environment

This position reports to the Quality Manager and is part of a team of 10 within the Quality group. The role requires 100% onsite work at the manufacturing facility in Sparta, NJ. The work breakdown is approximately 80% on the manufacturing floor and 20% based at a desk. The company offers growth potential and values high-achieving individuals who can influence decision-making processes and contribute to the company's agile environment.

Pay and Benefits

The pay range for this position is $60000.00 - $100000.00

Medical Plans
Dental Plan
Vision Plan
Flexible Spending Accounts (FSA)
Life and AD&D Insurance
Disability Insurance
Employee Assistance Program (EAP)
LifeReferrals 24/7 Program
401(k)
Cost of Benefits
Contact Information

Workplace Type

This is a fully onsite position in Sparta,NJ.

Application Deadline

This position will be accepting applications until Feb 3, 2025.

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 for other accommodation options.