RESPONSIBILITIES
Performs bio-analytical methods (Chemistry lab) for various Bio QC Tests on raw materials, in-process, release or stability samples in compliance with 9CFR, EU and VICH regulatory guidelines, outlines of production and special outlines. Will initiate, execute and complete assays as per validated procedures and within quality and compliance guidelines. Responsible for timely communication with supervisors to inform them of testing, compliance and/or scheduling issues, adhering to company policies, maintaining a safe work environment through site safety KPIs, living out the Lead principles and following appropriate GMP documentation.
Skills:
Previous work in GMP environment desired Experience with the following test is preferred: conductivity, wet chemistry testing, loss on drying, particle size analysis, specific optical rotation, viscometry
EXPERIENCE
An entry level position. This is going to be a lot of support role logging in and tracking of samples, but it will also include a technical component. Do a lot of wet chemistry or bench chemistry; lot of compendial testing. Experience with monograph testing or Compendial Testing, that is going to be really helpful.
Must Have Requirements:
· Bachelor of chemistry, biology, or related field or Recent graduate
· Looking for 0-2 years of experience.
· Instruments that would be really important: PH conductivity meter, UV-vis refractometers.
NICE TO HAVES:
· Conductivity for water monitoring
· Understanding about good documentation practices following GDP principles.
· And experience in a regulated environment before for a short term, that would be helpful. But there is training provided.
EDUCATION
Bachelor in chemistry or the biological sciences Entry level role for recent graduate
To be a best-fit your strengths must include:
Strong Communicator. You will have extensive correspondence that relies on you being conversant in regulatory guidelines and clinical terminology.
Organized. You’re an efficient time-manager and can handle the pressure of meeting multiple strict deadlines.
Ability to work independently and with a team: You will be collaborating and often contributing to discussions amongst internal teams; you also work effectively without a lot of support or structure.
Problem-Solvers. As an action-oriented self-starter, you’re eager to apply your expertise in diagnosing inefficiencies, determining root causes, and recommending solutions to complex challenges.
Personable. You establish and nurture highly effective relationships with colleagues and key stakeholders that support and advance project goals and objectives.
Credible. Thorough understanding of clinical methodologies and providing sound analytical support, you quickly establish credibility as a reliable resource.
About Advanced Clinical
Advanced Clinical is an award-winning clinical development organization that provides global services including CRO, Functional Support, Quality & Validation, Patient Recruitment and Retention, and Strategic Talent Acquisition solutions for pharmaceutical, biopharmaceutical, biotechnology, and medical device organizations. Our mission is to deliver a truly better clinical experience for our clients and candidates. To learn more about Advanced Clinical which has been named to Chicago Tribune’s Top Workplaces, Chicago’s Best and Brightest Companies, and Best of Staffing Talent & Client, visit http://www.advancedclinical.com.
Regarding your application
Please know that every completed application is carefully reviewed by the Advanced Clinical recruitment team. We understand the time commitment that is needed to prepare an application, so we respect your effort by thoughtfully reviewing and responding to each application. In return, we ask for your patience as careful review takes time, and we may not be able to respond to every application immediately.
It is Advanced Group’s practice not to discriminate against any employee or applicant because of sex, race, color, age, national origin, religion, gender, gender identity/expression, sexual orientation/sexual preference, pregnancy/maternity, genetic information, marital status, physical/mental disability, medical condition, military/veteran status, or any other basis protected by applicable federal, state, or local law. If you have a disability or handicap and would like us to accommodate you in any reasonable way, please inform your recruiter so that we can discuss the appropriate alternatives available.
