Analyst QC

Bora Pharmaceuticals Inc; Maple Grove (MN); On-site; USD 52,000 - 65,000; Full time

Benefits offered by this job

Health coverage

Retirement plan

Paid time off

Professional development

Wellness program

Employee Assistance Program

Job summary

The Analyst QC provides analytical and technical support for the analysis of raw materials (drug substances, excipients, in-process materials, and packaging components), stability samples, and drug products. Completes testing in a timely manner according to cGMPs, test methods, and SOPs.

Works with dissolution, ion chromatography, pH meters, balances, and various other auxiliary laboratory equipment. Reasonable accommodations will be made to enable individuals with disabilities to perform the

Qualifications

• Bachelor’s degree in chemistry or related science field (0 years' experience) OR a high school diploma or equivalent with a minimum of 4 years of laboratory experience.
• Experience in a pharmaceutical laboratory and analytical chemistry knowledge is preferred.

Responsibilities

• Performs testing on raw materials, in-process materials, finished products, and stability samples.
• Accurately documents testing in an electronic notebook and communicates out-of-spec results to management.
• Maintains a clean, safe laboratory environment and operates dissolution and related instrumentation.

Skills

Laboratory testing

Analytical chemistry

Education

Bachelor’s degree in Chemistry

High school diploma + 4 years lab experience

Tools

HPLC

UV

FTIR

Job description

Job Summary

The Analyst QC provides analytical and technical support for the analysis of raw materials (drug substances, excipients, in-process materials, and packaging components), stability samples, and drug products. Completes testing in a timely manner according to cGMPs, test methods, and SOPs. Works with dissolution, ion chromatography, pH meters, balances, and various other auxiliary laboratory equipment. Reasonable accommodations will be made to enable individuals with disabilities to perform the essential functions.

Essential Job Functions

Performs testing on raw materials, in-process materials, finished products, and stability samples to support department testing timelines. Must perform tests accurately and with minimal errors. Performs dissolution testing, including system set up, sample introduction, sample pulls, analysis on instrumentation, as applicable, and clean up. Demonstrates an understanding of applicable test methods and a familiarity with compendial testing requirements. Responsible for communicating atypical and out-of-specification results to laboratory management. Accurately documents testing in an electronic laboratory notebook and makes necessary corrections in a timely manner according to appropriate SOPs. Cleans laboratory glassware, equipment, and common work areas. Responsible for maintaining a clean work area. Aids in ensuring that the laboratory environment is safe. Works independently or in a team setting with minimal supervision. Is accountable for the completion of individual responsibilities. Maintains awareness of the USP and other applicable pharmacopeia. Performs compendial testing according to the monographs and general chapters. Demonstrates cooperation and professionalism with team members and other members of the Bora organization. Proficient with maintaining and using basic laboratory equipment to perform qualitative and quantitative testing. Operates intermediate level instrumentation (e.g., dissolution, UV) and related software with support. Works with supervisor to prioritize activities. Shifts priorities to meet business demands. Notifies management when timelines cannot be met. 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

A bachelor’s degree in chemistry or related science field (0 years' experience) OR a high school diploma or equivalent with a minimum of 4 years of laboratory experience, preferably in the pharmaceutical industry and with analytical chemistry knowledge. Experience working in a laboratory environment is preferred, preferably in the pharmaceutical industry.

Other Knowledge, Skills and Abilities

Develops efficiencies in their day-to-day testing. Increases their productivity and maintains their work while minimizing errors. Develops familiarity with HPLC, UV, FTIR, and other relevant laboratory equipment, as necessary. Has experience using Microsoft Word, Excel, and other computer software systems. Required to wear safety glasses and lab coat while in the lab area. May be required to wear other protective equipment such as goggles, gloves, ear protection, etc.

Compensation Range

$52,000 - $65,000 Compensation for the role will depend on a number of factors, including a candidate’s qualifications, skills, competencies and experience.

Compensation and Benefits

• 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

Core Values

At Bora, our values guide everything we do — from how we solve challenges to how we support our people. We lead with a solutions-first mindset, strive to do the right thing, stay proactive, and above all, respect everyone.

Bora Pharmaceuticals is committed to providing equal employment opportunity to all applicants and employees according to all applicable equal opportunity and affirmative action laws, directives and regulations of federal, state and local governing bodies and agencies. In keeping with this commitment, Bora Pharmaceuticals will recruit, hire, train and promote persons in all job titles, without regard to race, color, creed, religion, sex (including factors related to pregnancy or child birth), national origin, age, marital status, familial status, disability, sexual orientation, gender identity status with regard to public assistance, employment status, local human rights commission activity, status as a protected veteran, genetic information, atypical hereditary cellular or blood trait, or any other protected category.

Bora Pharmaceuticals is focused on developing and manufacturing branded, generic and over the counter (OTC) healthcare and pharmaceutical products for patients around the globe. At Bora Pharmaceuticals, we see it as our mission and our duty to make our mutual success more certain. As an ambitious, future-focused company, we know better than most that our own success is shaped by our partners victories.