High School Diploma with 4+ years of analytical testing experience, or an Associate's degree with 3 years, or a Bachelor's degree with 2 years of related experience.
Proficiency in HPLC, CE, icIEF, and Subvisible Particle analysis, as well as basic methods like UV absorbance, pH, conductivity, and osmolality.
Strong understanding of cGMP standards and good laboratory practices.
Experience in Quality Control and GMP testing is essential.
Ability to perform data entry and peer review in a laboratory setting.
Responsibilities
Conduct routine and complex analytical testing in compliance with protocols and cGMP standards.
Enter and manage data in the Laboratory Information Management System (LIMS).
Perform peer reviews of test data to ensure integrity and compliance.
Report out-of-specification results and assist in laboratory investigations.
Initiate and monitor Quality event records and conduct root cause investigations.
Maintain laboratory cleanliness and equipment, escalating issues as necessary.
Prepare lab reagents and buffers, ensuring proper monitoring of expiration dates.
Benefits
Comprehensive health coverage including medical, dental, and vision insurance.
Retirement savings plans with employer matching contributions.
Paid time off to support work-life balance.
Professional development opportunities for career growth.
Employee wellness programs and resources to promote health.
Employee Assistance Program and Mental Health Resources.
Full Job Description
Job Summary:
This position is responsible for performing activities to support analytical testing programs at Bora Biologics USA, LLC. to ensure compliance with cGMP standards including in-process, product release and stability testing. This individual will be required to complete the testing and related documentation in a timely manner while adhering to standard operating procedures and under cGMPs.
Essential Functions:
Reasonable accommodations will be made to enable individuals with disabilities to perform the essential functions.
Responsibilities and Job Duties
Performs routine analytical testing including more complex methods such as HPLC, CE, icIEF, and Subvisible Particle analysis as well as basic methods such as concentration by UV absorbance, pH, conductivity, and osmolality, for in-process, product release, and stability samples on a daily basis in accordance with all protocols and procedures.
Enters data into Laboratory Information Management System (LIMS).
Performs peer review of test data generated by other analysts as needed to ensure data integrity and adherence to standard operating procedures and GMPs.
Reports out-of-specification results from testing to supervisor and assists with performing laboratory investigations to determine the root cause and possible resolution.
Initiates and monitors progress of analytical related Quality event records (e.g., Deviations and CAPAs) and conducts investigations to determine root cause and possible resolution.
Performs routine lab cleaning and equipment maintenance activities in accordance with SOPS as scheduled, and escalates potential equipment issues to supervisor.
Prepares general lab reagents and buffers as needed and monitors expiration dates.
Identifies opportunities for process improvement and makes recommendations to team leader.
Revises and updates standard operating procedures, as needed.
May participate in special projects related to problems encountered with testing and instruments, and make recommendations for solutions that will minimize future issues.
Performs other duties as assigned.
The above statements are intended to describe the nature of work performed by those in this job and are not an exhaustive list of all duties. Nothing in this job description restricts managements right to assign or reassign duties and responsibilities to this job at any time which reflects management's assignment of essential functions.
Minimum Education, Experience & Skills:
High School Diploma and minimum of four (4) years of experience in performing analytical/chemistry testing.
Associate's degree in a scientific area of study with three (3) years of related experience
Bachelor's Degree in a scientific discipline and minimum of two (2) years of direct related experience.
Experience in one or more of the following areas required: HPLC, CE, icIEF, and Subvisible Particle analysis, UV absorbance, pH, conductivity, osmolality, Quality Control, and GMP testing.
Strong knowledge of good laboratory practices.
Salary Range: $74,000-$87,000
Compensation and Benefits
We offer a comprehensive benefits package designed to support our employees' wellbeing, including:
Competitive salary and performance-based incentives
Comprehensive health coverage including medical, dental, and vision insurance
Retirement savings plans with employer matching contributions
Paid time off
Professional development opportunities
Employee wellness programs and resources
Employee Assistance Program and Mental Health Resources
About Upsher-Smith
Upsher-Smith Laboratories, LLC is a pharmaceutical company headquartered in Maple Grove, Minnesota. The company was founded in 1919 and is now a subsidiary of Sawai Pharmaceutical Co., Ltd. Upsher-Smith develops, manufactures, and markets prescription and over-the-counter products in the areas of women's health, dermatology, cardiology, and neurology. The company has a strong commitment to quality and innovation, and is dedicated to improving the health and well-being of patients.
