The final salary or hourly wage, as applicable, paid to each candidate/applicant for this position is ultimately dependent on a variety of factors, including, but not limited to, the candidate's/applicant's qualifications, skills, and level of experience as well as the geographical location of the position.


Applicants must be legally authorized to work in the United States. Sponsorship not available.


Our client is seeking a Assistant QC Scientist in New Jersey.


Role Description


Purpose:
The QC Analyst is responsible for supporting Quality Control bioanalytical testing for release of clinical and commercial products. 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.


Duties and Responsibilities
• Perform testing of in-process, final product, stability samples, and method transfer.
• Utilize scientific principles to assist in analytical testing methods and the proper use of laboratory equipment.
• Anticipate and troubleshoot problems.
• Recommend corrective actions and participate in the development of best practices.
• Understanding of regulatory guidelines.
• Complete all work in a timely manner.
• Work and communicate effectively within the team to ensure timelines are met.
• Apply technical knowledge and abilities to ensure all testing is performed in a compliant manner.
• Communicate effectively with peers, and demonstrate teamwork, regarding results of review and
corrections required.
• Document training per procedural and cGMP requirements.
• Perform assigned tasks within a CAPA, deviation, or project
• Draft and review technical documents, such as SOPs and forms.
• Communicate effectively with management regarding task completion, roadblocks, and needs.
• Performs other tasks as assigned.


Skills & Requirements


Required Competencies: Knowledge, Skills, and Abilities
• Hands-on experience with various bioanalytical techniques including ELISA, qPCR and FACS and cell-based
assays.
• Experience in assay transfer, technology transfer, validation from Analytical Developmental group to Quality
Control group.
• 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 set priorities of the group and manage timelines.
• Ability to work with management locally and globally.
• Ability to communicate effectively with peers, department management and cross-functional peers.


Education and Experience
• Bachelor's degree required, preferably in Science.
• 2-3 years of relevant work experience, preferably in a regulated environment.
• An equivalent combination of education and experience may substitute. EX: if the person has a Master degree but
less exp. (1-2 years), manager would still consider that candidate.


Benefits/Other Compensation


This position is a contract/temporary role where Hays offers you the opportunity to enroll in full medical benefits, dental benefits, vision benefits, 401K and Life Insurance ($20,000 benefit).


Why Hays?


You will be working with a professional recruiter who has intimate knowledge of the industry and market trends. Your Hays recruiter will lead you through a thorough screening process in order to understand your skills, experience, needs, and drivers. You will also get support on resume writing, interview tips, and career planning, so when there's a position you really want, you're fully prepared to get it.


Nervous about an upcoming interview? Unsure how to write a new resume?


Visit the Hays Career Advice section to learn top tips to help you stand out from the crowd when job hunting.


Hays is committed to building a thriving culture of diversity that embraces people with different backgrounds, perspectives, and experiences. We believe that the more inclusive we are, the better we serve our candidates, clients, and employees. We are an equal employment opportunity employer, and we comply with all applicable laws prohibiting discrimination based on race, color, creed, sex (including pregnancy, sexual orientation, or gender identity), age, national origin or ancestry, physical or mental disability, veteran status, marital status, genetic information, HIV-positive status, as well as any other characteristic protected by federal, state, or local law. One of Hays' guiding principles is 'do the right thing'.
We also believe that actions speak louder than words.
In that regard, we train our staff on ensuring inclusivity throughout the entire recruitment process and counsel our clients on these principles. If you have any questions about Hays or any of our processes, please contact us.


In accordance with applicable federal, state, and local law protecting qualified individuals with known disabilities, Hays will attempt to reasonably accommodate those individuals unless doing so would create an undue hardship on the company. Any qualified applicant or consultant with a disability who requires an accommodation in order to perform the essential functions of the job should call or text 813.336.5570.


Drug testing may be required; please contact a recruiter for more information.


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#1167862 - Laurie McComb