Contract Quality Assurance Specialist

Overview

At the heart of QIAGEN’s business is a vision to make improvements in life possible.

We are on an exciting mission to make a real difference in science and healthcare. We are still the entrepreneurial company we started out as and have today achieved a size where we can bring our full power to many initiatives and to our presence across the globe. Our most valuable asset are our employees – more than 6000 in over 35 locations around the world. Our ambition is to ensure we have outstanding and passionate people working in the best teams and we are constantly looking for new talent to join us. There are few players who have shaped the world of modern science and healthcare as much as QIAGEN, and we have only just started.
If you are looking to advance your career, are seeking new challenges and opportunities, enjoy working in dynamic and international, diverse teams and want to make a real impact on people’s lives, then QIAGEN is where you need to be.

Join us. At QIAGEN, you make a difference every day.

Position Description

The Contract Quality Assurance Specialist reports to the Quality Assurance Director. Assists with all QA compliance activities; including reviews of CAPAs, deviations, NCMRs, customer complaints and recalls. Position responsibilities also include participation at internal and external regulatory audits, document reviews and support of companywide QA initiatives.

The contract duration is 6 months.

Job performance will involve a variety of activities including:

• Work in collaboration with product development to ensure that the designs, procedures and outcome of the project are acceptable in quality.
• Support the creation and the maintenance of Risk Management plans including dFMEAs, pFMEAs and Control Plans.
• Write or review and approve equipment IQ/OQ and assay Verification/Validation studies in collaboration with cross-functional teams.
• Conduct and support investigations of manufacturing nonconformities, recommend, develop and implement effective corrective actions.
• Conduct and support complaint handling activities such as intake, evaluation, investigations and reporting.
• Applies statistical methods for analyzing data to evaluate the current process and process changes and solve problems.
• Coordinates, collects, analyzes and distributes quality monthly and quarterly metrics
• Participates on audits conducted by regulatory agencies and/or customers.
• Participates in supplier evaluation and selection assessments.
• Maintains a working knowledge of industry standards. Knows and follows the ISO quality system guidelines.
• Performs external vendor audits to ensure ISO and/or FDA compliance.
• Additional responsibilities may be assigned as needed.

Position Requirements

• Between 1-3 years of QA experience in an ISO and/or FDA regulated environment
• Bachelor's degree from four year College or university preferably in a life science discipline, or equivalent experience
• Experience with ISO 13485 certification, FDA 21 CFR 820 and 21 CFR Part 11 preferred
• Experience in a Good Manufacturing Practice (GMP) environment preferred

Personal Requirements

• Attention to detail
• Drive and Determination
• Positive external and internal relationship management skills
• Ability to participate with other members of the team to ensure that demanding and difficult projects are handled smoothly and cooperatively to enhance success of project and maintain strong relationships within all parts of company
• Proven ability to thrive in a change oriented environment
• Must be proficient in MS Office (Outlook, Teams, Word, Excel, PowerPoint)

QIAGEN requires proof of full COVID-19 vaccination as a condition of employment for new hires in all U.S. states other than Montana effective as of September 1, 2021. New hires and candidates will be required to present proof of full COVID-19 vaccination within three business days of start date or upon entry into the office (i.e., for interviews), whichever comes first. QIAGEN complies with applicable laws regarding the confidentiality of employee health information and the reasonable accommodation of individuals with disabilities and/or sincerely held religious beliefs. Candidates who require accommodation should contact Benefits@QIAGEN.com. This policy is part of QIAGEN’s ongoing efforts to support public health efforts and to ensure the safety and-well-being of its employees, customers, business partners, and community.

What we offer

At the heart of QIAGEN are our people who drive our success. We act with passion, always challenging the status quo to drive innovation and continuous improvement. We inspire with our leadership and make an impact with our actions. We create a collaborative, safe and engaging workplace which forms the basis for high performing individuals and teams. We drive accountability and entrepreneurial decision-making and want you to excel your growth and shape the future of QIAGEN.

QIAGEN is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, and medical conditions related to pregnancy, childbirth, or breastfeeding), sex stereotyping (including but not limited to assumptions about a person’s appearance or behavior, gender roles, gender expression, or gender identity), gender, gender identity, gender expression, national origin, age, mental or physical disability, ancestry, medical condition, marital status, military or veteran status, citizenship status, sexual orientation, genetic information, or any other status protected by applicable law.

Job Type: Contract

Schedule:

• 8 hour shift
• Monday to Friday

Ability to commute/relocate:

• Germantown, MD: Reliably commute or planning to relocate before starting work (Required)

Experience:

• Quality assurance: 1 year (Required)

Work Location: In person