QC Lab Mgr
1 st shift (M-F / 8am-5pm)
Min 5 years experience in a QC Lab role from an FDA regulated facility/experience (Food/Pharma/Chemical)
Previous supervisory/management experience
BS in Chemistry/Biochemistry preferred
location: Junction City, Kansas
job type: Permanent
salary: $70,000 - 80,000 per year
work hours: 8 to 4
education: Bachelors
responsibilities:
The Role
This position serves as the Lab Manager for Ventria's Quality Control department at our manufacturing facility in Kansas (near Manhattan, KS). The role is responsible to conduct product release and in-process testing according to Ventria's Quality Management Syste (QMS) and standard operating procedures (SOPs) in a timely manner to move product from quarantine into product available for sale. This position will have one direct report with additional direct reports based on performance and expansion of the business. A successful candidate must have practical experience working as a manager in a quality control laboratory setting where timeliness and commitment is required for success. Ventria Bioscience requires candidates to have a right to work in the USA without sponsorship, although exceptions would be made for qualified candidates that may require sponsorship as a result of relocation to the USA due to the crisis in Ukraine/Russia.
The candidate would work closely with QC analysts, quality assurance, manufacturing, supply chain, scientists, analytical development, and regulatory. The position reports to Ron Backman, Ventria's Vice President, Quality.
Essential Responsibilities
- Perform analysis of identity, purity and impurity using biochemistry methods under SOPs.
- Execute QC activities in accordance with Quality Management System and Standard Operating Procedures:
- Order and inspect reagents and supplies for use in the QC Lab
- Monitor and/or calibrate equipment used in the QC Lab
- Complete required analytical and microbiological testing of in-process materials and equipment change overs
- Complete required analytical and microbiological testing to facilitate the completion of Product Certificates and assist in QA Lot Release activities
- Draft and update SOPs and forms used within the QC Lab
- Assist VP Quality with internal audits and external audits
- Identify areas of improvement for the QC Lab and help to implement solutions
- Assist in the implementation of IS09001 and maintain cGMP compliance within the facility
- Perform Environmental Services (ES) sampling and monitoring as required
- Perform QC Lab sanitization/disinfection and help to maintain aseptic controls
- Assist in the implementation of reliable and repeatable assays
- Data reported on Product Certificates is accurate
- Investigate other assays and methodologies that are standards in the industry
- As a member of the Quality team, support achievement of performance metrics established for:
- Quality
- Quantity
- Production Costs/Cost-per-Gram/Cost-per-Assay
- Safety
- Maintenance
- Timeliness
- Maintain and report status on the QC Lab and QC Lab equipment
- Fulfillment of customer orders are not delayed due to out-of-service equipment in the QC Lab
- Identify opportunities and help to make the business case to purchase new equipment for the QC Lab
- Maintain equipment qualification and assay validation standards
- Act and perform your job with high integrity and in compliance of all laws and regulations
- Comply with all company policies.
qualifications:
Qualifications/Requirements
- Minimum of 5 years' experience supervising an analytical or microbiological laboratory with direct supervisor experience required.
- Minimum B.S. in a technical degree such as Chemistry, Biology, Biochemistry, from a leading US-based institution such as Kansas State University, Iowa State University, Oklahoma State University, University of Nebraska, University of Kansas, University of Texas, University of Oklahoma, Cornell, Ohio State University, Purdue, Washington State University, University of Wisconsin, University of Missouri, University of Georgia, or related;
- A can-do attitude with curiosity and willingness to learn about the Company's products and technologies.
- Highly motivated as evidenced by previous performance and record of advancement.
- Familiarity with any or all of the following analytical methods:
- Gel electrophoresis,
- pH,
- ELISA,
- rFC and LAL endotoxin determination,
- bioburden,
- HPLC-Size Exclusion,
- HPLC-Reverse Phase ,
- Capillary Westerns.
- Strong analytical and organizational skills;
- Strong oral and written communication skills and presenting technical information with clarity and logic.
- Experience with the Microsoft Office 365 suite of products, including Outlook, Sharepoint, Word, Excel, and PowerPoint;
- Masters or Ph.D. in engineering is a plus.
- Familiar with project management tools such as GANT charts, critical path planning and budgeting.
- Statistical analysis software skills such as GraphPad/Prism, JMP, SAS, SPSS or related.
skills: GLP (Good Laboratory 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.
EOEDisclaime For certain assignments, Covid-19 vaccination and/or testing may be required by Randstad's client or applicable federal mandate, subject to approved medical or religious accommodations. Carefully review the job posting for details on vaccine/testing requirements or ask your Randstad representative for more information.
