Quality Assurance Associate

Actalent is seeking a Quality Assurance Associate to support a robust quality system by managing product complaints, conducting investigations, and ensuring compliance with applicable regulations and internal procedures.

About the role

This role independently handles customer inquiries, performs detailed complaint evaluations, supports regulatory reporting, and contributes to process improvements that enhance product quality and customer satisfaction.

Responsibilities

• Independently field inquiries received by phone, electronic, or verbal correspondence and determine whether they qualify as complaints in accordance with applicable standard operating procedures.
• Document reported issues accurately and completely, following all relevant SOPs and quality system requirements.
• Provide technical support and remote troubleshooting guidance to users and customers as needed.
• Review associated records independently and contact users and customers to collect detailed information on treatments, product performance, and functionality.
• Conduct periodic follow-up with customers and internal stakeholders to ensure timely closure of complaints.
• Manage customer relationships and expectations throughout the complaint investigation process, maintaining clear and professional communication.
• Independently complete complaint investigations, including coordinating or executing product returns and subsequent evaluations as required.
• Review manufacturing records and other relevant documentation as part of complaint investigations, ensuring proper approvals are obtained prior to closure.
• Develop practical solutions to a variety of moderately complex problems related to product quality and performance.
• Conduct statistical analysis of complaint trends and provide insights that support quality improvement initiatives.
• Support the training program by training users on the complaint process, tools, and methods used to assess and investigate complaints.
• Support and, when appropriate, identify operational changes to improve efficiencies in all aspects of complaint handling.
• Lead investigations associated with product deviations, product non-conformances, corrective and preventive actions (CAPAs), scrap, and rework, and analyze data to identify root causes and opportunities for quality improvement.
• Update internal operating procedures and specifications through the document change process to reflect process improvements and regulatory requirements.
• Support and participate in internal quality system audits by providing documentation, explanations, and follow-up actions.
• Support external quality system audits by assisting with preparation, participating in audit activities, and implementing corrective actions as needed.
• Evaluate complaints to determine whether submission of a Medical Device Report (MDR) or other Vigilance Report is required based on regulatory criteria.
• Prepare and submit MDRs and Vigilance Reports within required regulatory timelines, ensuring accuracy and completeness of information.

Requirements

• Bachelor of Science (BS) in a Physical Science or Engineering, or equivalent experience (required).
• Experience working within a quality system in a regulated industry, such as medical devices, pharmaceuticals, or related fields (preferred).
• Experience in quality assurance or other regulated industry or similar experience (preferred).
• Knowledge of quality principles and practices, including inspection activities.
• Familiarity with FDA regulations and expectations for regulated products.
• Understanding of Good Manufacturing Practices (GMP).
• Understanding of Good Laboratory Practices (GLP).
• Experience or exposure to medical device (Med* Device) quality or regulatory environments.

Skills

• Strong technical writing skills, with the ability to document investigations, complaints, and reports clearly and accurately (required).
• Strong general problem-solving skills and the ability to develop solutions to moderately complex issues (required).
• Ability to manage multiple priorities and work effectively despite interruptions (required).
• Customer service skills, including the ability to manage customer expectations and maintain professional communication.
• Proficiency with Microsoft Excel for tracking, trending, and statistical analysis of complaint data.
• Experience supporting or participating in internal and external quality system audits.
• Experience with complaint handling processes, including documentation, investigation, and closure.
• Familiarity with Medical Device Reporting (MDR) and Vigilance reporting requirements and timelines.
• Ability to adapt to constant and sometimes sudden changes in role, processes, or organizational priorities.
• Strong interpersonal and communication skills for collaborating with cross-functional teams and training users on complaint processes.
• Attention to detail and accuracy in documentation, data analysis, and regulatory reporting.

Work Environment

This is a first-shift position with core hours of 7:00 a.m. to 3:30 p.m., Monday through Friday, with an additional hour of work per day expected. There may be occasions when work of up to four hours on Saturdays is requested; while this is typically voluntary, candidates should be comfortable and capable of working Saturdays as required.

The work environment supports a family-oriented culture where team members actively support one another and collaborate to achieve shared goals. The organization regularly undergoes change, so the ideal candidate is comfortable working in a dynamic environment where responsibilities and processes may evolve.

The role operates within a regulated quality system environment, using standard office and computer-based tools such as Microsoft Excel, and involves frequent communication by phone and electronic correspondence with customers and internal teams.

Pay

The pay range for this position is $24.00 - $26.00/hr. Individual compensation offered for this position within this range will depend on many factors, including qualifications, skills, relevant experience, job knowledge, geographic location, internal equity, and other pertinent job-related factors.

Benefits

Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following:

• Medical, dental & vision
• Critical Illness, Accident, and Hospital
• 401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available
• Life Insurance (Voluntary Life & AD&D for the employee and dependents)
• Short and long-term disability
• Health Spending Account (HSA)
• Transportation benefits
• Employee Assistance Program
• Time Off/Leave (PTO, Vacation or Sick Leave)

Schedule

• First-shift: 7:00 a.m. to 3:30 p.m., Monday through Friday, with an additional hour of work per day expected.
• Occasional Saturday work (up to four hours) may be requested.