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You will be responsible for manufacturing products for the Bulk Formulations TDM team and complete associated cGMP documentation. You will work with chemicals and biologicals to manufacture reagents, calibrators, and controls for IVD immunoassay use and participate in process improvement projects.
What will you do? Manufacture products including reagents, calibrators, buffers, controls, etc. and complete batch records while maintaining cGMPs and GDP standards Perform in-process testing using clinical analyzers and analyze raw data for in-process adjustments and product release Review other manufacturing operators/scientists batch records Maintain and analyze lot histories for trends and discrepancies Perform laboratory activities including weighing, transferring, and mixing required chemicals and performing product filtration Participate in process improvement projects to improve operational efficiencies and support business needs Modify SOPs, work instructions and reports with mentorship Initiate and support investigations for quality documentation including NCARS, CAPAs, and Variances Maintain and troubleshoot testing and formulations equipment as appropriate Keep department supervisor and/or manager updated on all issues Perform other job duties as the need arises
How will you get here? Education BS/BA in a scientific field in Chemistry, Biochemistry, or related technical discipline; equivalent combination of education and years of related experience may be substituted
Experience 1+ years of related experience and/or training preferred Laboratory skills including pipetting, safety, and hazardous chemical handling and knowledge of safety precautions Experience in working with potentially hazardous chemicals and human source materials preferred Familiarity with Quality System Regulations and ISO 13485 regulations is a plus IVD immunoassay manufacturing experience preferred
Knowledge, Skills, Abilities Ability to perform tasks in compliance with GMP, GDP, QSRs, ISO and IVD regulations Must be organized, detail-oriented, and can prioritize own and others work to meet business efficiency metrics Self-sufficient, self-motivated, and focused Ability to routinely lift 25 pounds Exact Schedule - M-F 8am-5pm Fully Onsite
The base pay range above represents the low and high end of the base compensation range we reasonably expect to pay for this position. Actual base compensation will vary and may be above or below the range based on various factors including, but not limited to, geographic location, actual experience, and job performance. This job posting is not a promise of any specific pay for any specific employee.
The range listed is just one component of the total compensation package for our employees. Based on the details of your position, we provide a variety of benefits to our employees, including medical, dental, and vision plans, pre-tax savings plans, pre-tax parking and commuter plans, supplemental health and welfare plans, a retirement savings plan, an employee assistance program, pet insurance, and paid holidays. Other rewards may include short-term incentives and paid time off.
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About Advantage TechnicalWith company roots going back over 30 years, Advantage Technical is an engineering and information technology services company and a national leader in the provision of technical resources today. These services include Staff Augmentation, Direct Placement, Project Resourcing and Outsourcing - delivered from 40 key market locations, by over 3500 specialized contractors, to over 500 clients across North America. Advantage Technical is a Best of Staffing Diamond Award winner for both Clients and Talent. For more information about the industries and services offered by Advantage Technical, please visit .
Advantage Technical is committed to providing equal employment opportunity for all persons regardless of race, color, religion (including religious dress and grooming practices), sex, sexual orientation, gender, gender identity, gender expression, age, marital status, national origin, ancestry, citizenship status, pregnancy, medical condition, genetic information, mental and physical disability, political affiliation, union membership, status as a parent, military or veteran status or other non-merit based factors. We will provide reasonable accommodations throughout the application, interviewing and employment process. If you require a reasonable accommodation, contact us. Advantage Technical is an E-Verify employer. This policy is applicable to all phases of the employment relationship, including hiring, transfers, promotions, training, terminations, working conditions, compensation, benefits, and other terms and conditions of employment.
All employees are directed to familiarize themselves with this policy and to act in accordance with it. All decisions with respect to employment matters and other phases of employer-temporary employee relationships will be in keeping with this policy and in accordance with all applicable laws and regulations.