Quality Assurance Associate

Ashfield Healthcare, LLC; Yardley (WA); Hybrid; USD 35,000 - 65,000; Full time

Benefits offered by this job

Medical, dental, and vision coverage

401(k) with company match

Paid time off

Paid holidays

Job summary

Inizio Engage is seeking a QA Associate to support day-to-day QA customer correspondence, mail merges, and material retrieval processes for a leading biotechnology client. This hybrid role involves 3 days onsite at the Wilmington, DE office and 2 days remote, with a focus on accuracy, regulatory compliance, and timely customer communications.

The successful candidate will have a Bachelor’s degree or equivalent, quality/compliance experience in pharma, excellent Excel skills, and strong

Qualifications

• Bachelor’s degree or equivalent work-related experience.
• Quality/compliance experience within pharmaceutical industry.
• Excellent Excel skills required.
• Excellent verbal, written and listening communication skills.
• Demonstrated competency using information technology, PCs and databases.
• Ability to multitask with accuracy.

Responsibilities

• Manage and respond to email inquiries.
• Complete mail merge from Client databases for QA department.
• Complete reconciliation of adverse event and product complaint reporting.
• Assist pharmaceutical manufacturing sites with sample/customer mailing inquiries.
• Follow up with internal and external customers when more information is required on product quality complaints and adverse events.
• Provide world-class customer service and immediate resolution to inquiries at the point of customer contact.
• Meet customer satisfaction levels.
• Assemble mailers to customers for Product Complaint Retrievals.
• Maintain supply inventory for all correspondence and sample retrievals.
• Comply with industry regulations, policies, and procedures of client and Inizio.

Skills

Excellent Excel skills

Quality/compliance experience

Written and verbal communication

Multitasking with accuracy

Information technology and databases

Education

Bachelor’s degree or equivalent

Tools

Microsoft Excel

Job description

Inizio Engage has a long-standing partnership with a leading Biotechnology company, across Commercial, Patient Solutions and Medical Affairs businesses. The Quality Assurance ("QA") Associate is responsible for day-to-day handling of QA customer correspondence. This includes the daily file and mail merge of customer letters, assembly and mailing of sample retrieval materials and assuring that supplies to do such are available. The QA Associate will also support our client in areas where the two departments merge. Customers include Health Care Professional, patients, internal employees, and vendors. Key elements of the position are teamwork and attention to detail. Work environment is dynamic, high volume and dependent on accuracy. This is your opportunity to join Inizio Engage and represent a top biotechnology company! This is a hybrid position - 3 days onsite in the Wilmington, DE office and 2 days remote.

Why You’ll Love Working Here

• Competitive pay that recognizes your experience, expertise, and impact
• Comprehensive benefits including medical, dental, and vision coverage; accrued paid time off; 401(k) with company match; disability and life insurance; and paid maternity and paternity leave
• Company-paid holidays so you can rest, recharge, and focus on what matters most
• Recognition programs, contests, and awards that celebrate your contributions
• Continuous growth opportunities through learning, leadership development, and career advancement support
• A collaborative culture where your ideas are valued and your work makes a difference
• We’re also proud to be recognized for creating an exceptional employee experience: Best Place to Work in BioPharma — 2022, 2023, 2025 Certified Great Place to Work® — 2021, 2023, 2025, 2026
• Learn more: https://www.greatplacetowork.com/certified-company/7003732

What will you be doing?

• Manage and respond to email inquiries
• Complete mail merge from Client databases for QA department.
• Complete reconciliation of adverse event and product complaint reporting.
• Assist pharmaceutical manufacturing sites with any sample/customer mailing related inquiries.
• Follow up with internal and external customers when additional information is required on the product quality complaints and adverse events.
• Provide world-class customer service and immediate resolution to inquiries at the point of customer contact.
• Meet customer satisfaction levels.
• Participates as required in short-term project work in support of Product Quality Complaint management.
• Assembles mailers to customers for Product Complaint Retrievals.
• Maintain supply inventory for all correspondence and sample retrievals.
• Comply with all industry regulations, policies, and procedures of our client and Inizio.

What do you need for this position?

• Bachelor’s degree or equivalent work-related experience
• Must have quality/compliance experience within pharmaceutical industry
• Excellent excel skills required
• Excellent verbal, written and listening communication skills
• Demonstrated competency using information technology, PCs and databases
• Ability to multitask with accuracy
• Good time management, interpersonal and organizational skills
• Ability to work independently
• Ability to lift, carry and otherwise move up to 25 pounds
• Ability to sit, stand or walk for various lengths of time throughout the day

About Inizio Engage

Inizio Engage is a strategic, commercial, and creative engagement partner that specializes in healthcare. Our passionate, global workforce augments local expertise and diverse mix of skills with data, science, and technology to deliver bespoke engagement solutions that help clients reimagine how they engage with their patients, payers, people, and providers to improve treatment outcomes. Our mission is to partner with our clients, improving lives by helping healthcare professionals and patients get the medicines, knowledge and support they need. We believe in our values: We empower everyone/We rise to the challenge/We work as one/We ask what if/We do the right thing, and we will ask you how your personal values align to them.

Equal Opportunity & Inclusion

Inizio Engage is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to age, ancestry, color, gender, gender identity or expression, genetic information, marital status, medical condition (including pregnancy, childbirth, or related conditions), mental or physical disability, national origin, protected family care or medical leave status, race, religion (including beliefs and practices or the absence thereof), sexual orientation, military or veteran status, or any other characteristic protected by applicable federal, state, or local law. Inizio Engage is committed to providing reasonable accommodations in accordance with applicable law. Inizio Engage complies with applicable fair chance hiring laws and will consider qualified applicants regardless of criminal history. Where permitted by applicable law, employment offers may be contingent upon the successful completion of a background check. Any information obtained from a background check will be considered in relation to the requirements of the relevant position, consistent with applicable law.

Candidate Use of Artificial Intelligence in Interviews

As part of our commitment to a fair and equitable hiring process, candidates are expected to complete all interview activities without the use of artificial intelligence tools or external assistance unless such assistance is authorized in advance by Inizio Engage or otherwise required in accordance with applicable law. This includes, but is not limited to, using generative artificial intelligence platforms to produce, edit, or guide responses in real time. Candidates may be asked to confirm compliance with this policy. Any violation of this policy may result in disqualification from consideration of employment. Candidates may submit requests for reasonable accommodation in accordance with applicable law to the Inizio Engage Talent Acquisition team.

Salary

The base pay range for this position is $35K – $65K per year. The final compensation offered to a successful candidate will be determined by factors such as experience, skills, internal equity, and business needs.

Inizio Engage is a strategic, commercial and creative engagement partner that specializes in healthcare. Our passionate, global workforce augments local expertise and diverse mix of skills with data, science and technology to deliver bespoke engagement solutions that help clients reimagine how they engage with their patients, payers, people and providers to improve treatment outcomes. That’s why at Inizio Engage we’ve brought together a group of more than 7,000 experts, working in more than 20 countries. A passionate, diverse team with global reach and local knowledge. Together, we partner with our clients to challenge conventional thinking to empower people to make better health decisions and enhance treatment outcomes across the globe.