Bioanalytical QC Scientist needed in Summit, NJ for an American research-driven pharmaceutical company that strives to improve health of people and animals everywhere in the world. If you meet the requirements, please apply to this job. (Job ID 42284)
12 W2 Month Contract
Shift 9pm-7am Sunday-Wednesday
PURPOSE AND SCOPE OF POSITION:
The QC Associate Scientist is responsible for supporting Quality Control bioanalytical testing for the release of clinical and commercial products for QC Flow Cytometry Department. This department is responsible for Flow Cytometry based testing of in process samples, final drug product testing, stability testing, Validation and
requalification support, critical reagent testing and qualification, training and other critical support as needed. This includes the ability to interface with multiple groups, the ability to independently perform tasks, interpret results, and troubleshoot. Additionally, when needed, this position will be able to assist with training and assay transfer.
REQUIRED COMPETENCIES:
• Hands-on experience with various analytical techniques primarily flow cytometry and scientific knowledge in the characterization and transfer of pharmaceutical products.
• Ability to accurately and completely understand, follow, interpret and apply Global
Regulatory and cGMP requirements.
• Technical writing skills.
• Problem-solving ability/mentality, technically adept and logical.
• Ability to represent the interests of the group on cross-functional teams.
• Ability to work independently in a high-paced team environment, meet deadlines, and prioritize work from multiple projects.
• Ability to work with management locally and globally.
• Ability to communicate effectively with peers, department management and cross-functional peers.
MUST BE FULLY VACCINATED AGAINST COVID-19
Education and Experience:
• Bachelor's degree required, preferably in Science.
• Advanced Degree preferred.
• 0-3 years of relevant analytical testing or QC experience or equivalent combination of education and experience, preferably in a regulated environment.
DUTIES AND RESPONSIBILITIES:
Perform testing of the in-process, final product, and stability samples.
• Utilize scientific principles to assist in analytical testing methods and the proper use of laboratory equipment.
• Capable of handling complex issues and solving problems with only general guidance.
• Prepare and present continuous improvement projects to management.
• Comprehensive understanding of regulatory guidelines and can independently develop, write and execute methods, protocols, reports and other related documents.
• Complete all work in a timely manner.
Perform peer review of testing data.
• Review all data in accordance with applicable procedures and cGMP requirements.
• Apply technical knowledge and abilities to ensure all testing is performed in a compliant manner.
• Complete all reviews in accordance with required release timelines.
Communicate effectively with peers, and demonstrate teamwork, with regards to results of review and corrections required.
Train new analysts to general job duties.
• Complete necessary training to become a qualified trainer.
• Perform training effectively.
• Document training per procedural and cGMP requirements.
Support document revision, project, CAPA, and investigation/deviation tasks.
• Perform assigned tasks within a CAPA, deviation, or project
• Participate in complex projects and continuous improvement efforts.
• Take a leadership role, as required, for projects.
• Draft and review technical documents, such as SOPs and protocols/reports
• Communicate effectively with management regarding task completion, roadblocks, and needs.
• Demonstrate initiative, courage, and continuous improvement throughout investigation/corrective action lifecycles.
Opportunity is Calling, Apply Now!
Recruiter: Amanda Hutchins
What's In It For You?
We welcome you to be a part of one of the largest global staffing companies to meet your career aspirations. Yoh's network of client companies has been employing professionals like you for over 65 years in the U.S., UK and Canada. Join Yoh's extensive talent community that will provide you with access to Yoh's vast network of opportunities and gain access to this exclusive opportunity available to you.
- Medical, Dental & Vision Benefits
- 401K Retirement Saving Plan
- Life & Disability Insurance
- Direct Deposit & weekly ePayroll
- Employee Discount Programs
- Referral Bonus Programs
#LI-SA
#CB-SA
#Mon-SA