As the largest staffing and recruitment agency in the world, we can commit to finding you the perfect role that gives you the opportunity to learn and grow in the life sciences arena. Utilizing a recruiter for your job search gives you access to a large network of top employers as well as detailed information about hundreds of positions. A current top partnership with a research-driven biopharmaceutical company is known as a powerhouse that aims to develop treatments for difficult-to-cure diseases. This renowned employer has created 32 products, including Humira and Lupron, that have highly impacted lives across the globe. If you're looking to stand out in your field and lead the way to innovative therapies, this position is for you!
location: North Chicago, Illinois
job type: Contract
salary: $30.00 - 37.34 per hour
work hours: 9 to 5
education: Bachelors
responsibilities:
- In this role, you will initiate and manage product complaint records in the electronic system, determining investigation needs, leading activities, and documenting reports. You will gather complaint information by interfacing with external clinical investigators and partner companies. You will work with manufacturing and quality engineering to conduct investigations and implement CAPAs as needed. You will assess the risk and impact of complaints on clinical supplies and liaise with Post Marketing Quality to evaluate the reportability of complaints to regulatory agencies. Additionally, you will ensure consistency between product complaints and adverse event information in collaboration with safety organizations.
- Initiating and managing product complaint records; assessing the risk of complaints to patient safety and quality of clinical supplies; determining investigation needs for complaints; leading investigative activities across functional areas; gathering complaint information from clinical investigators and external partners; collaborating with partner companies on complaints.
qualifications:
Hybrid role (3 days onsite, 2 days remote), Flexible
- Bachelors (typically in life sciences (biology, chemistry, or engineering) and/or equivalent experience.
- 3+ years industry experience in Quality Assurance, production, testing of active pharmaceutical ingredients, drug products, drug development or other healthcare related field; less experience considered with advanced degree.
- Broad understanding of pharmaceutical manufacturing processes (chemical and biological), analytical sciences, and worldwide -global requirements for GMP (D, EU, US) is preferred.
- Proven organizational skills.
- Effective use of oral and written communication skills.
- Ability to identify and resolve complex problems through effective use of technical and interpersonal skills.
- Analytical and investigative mindset
- Strong oral and written communication skills
- Effective organizational abilities; comfortable with multitasking.
skills: Quality Assurance, CAPA, Biology, Chemistry, SAE (Serious Adverse Event), AD (Adverse Events), GMP (Good Manufacturing Practice)
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.
At Randstad, we welcome people of all abilities and want to ensure that our hiring and interview process meets the needs of all applicants. If you require a reasonable accommodation to make your application or interview experience a great one, please contact HRsupport@randstadusa.com.
Pay offered to a successful candidate will be based on several factors including the candidate's education, work experience, work location, specific job duties, certifications, etc. In addition, Randstad offers a comprehensive benefits package, including health, an incentive and recognition program, and 401K contribution (all benefits are based on eligibility).
This posting is open for thirty (30) days.
