Chemist II - QC

Bora Pharmaceuticals•Maple Grove, MN

2d•Onsite

About The Position

The QC Chemist II 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 and according to cGMPs, Test Methods, and SOPs. Maximizes efficiency by multitasking. Displays increasing productivity while minimizing errors. Provides leadership and technical expertise in response to problems (e.g., product investigations, analytical issues, and production problems). Coordinates and leads special projects. Shows strong technical writing skills. Mentors' junior analysts to assist in their career development. This is an onsite position.

Requirements

A Bachelor's Degree in Chemistry or related science field (with 12 credits of college chemistry)
Typically a minimum of 6 years' related experience, preferably in the pharmaceutical industry.
Has experience working in a laboratory environment, preferably in the pharmaceutical industry.
Demonstrates an understanding of applicable regulations and guidance (e.g., DEA, EPA, OSHA, and FDA).
Has an understanding of cGMP, USP, FDA, ICH, and other relevant guidance and regulations.
Provides technical support/research to assist other departments as necessary.
Has experience or training in using Microsoft Word, Excel, and other computer software systems (e.g., Empower).
Demonstrates a broad understanding of instrumentation to aid in maintenance and troubleshooting.

Nice To Haves

Experience with SAP and Biovia is preferred.

Responsibilities

Evaluates testing due dates and project timelines to help prioritize appropriate testing and is willing to shift priorities to meet business needs.
Consistently submits work that is right the first time. Provides guidance for others in submitting “right first time” work.
Has an in-depth knowledge of laboratory instrumentation and software (HPLC, GC, UPLC, Empower, Biovia) and is proficient with administrative software (e.g., SAP, Veeva). Demonstrates strong instrument troubleshooting skills.
Documents testing using an analytical laboratory notebook (Biovia) or laboratory notebook and aids in maintaining the laboratory according to appropriate GMPs and SOPs.
Responsible for communicating atypical and out-of-specification results to laboratory management.
Independently authors laboratory investigations and laboratory deviations for management review.
Ensures a safe and clean environment in the laboratory. Maintains personal laboratory work area and assists with general laboratory cleaning.
Works independently or in a team setting with minimal supervision.
Communicates well with team members and helps junior analysts prioritize their work appropriately.
Corresponds with outside vendors, compendial groups (USP, BP, etc.) and other departments with minimal supervision.
Participates in departmental and interdepartmental meetings as necessary.
Serves on project teams with support of laboratory management.
Possesses a strong understanding of the USP, ICH Guidelines, and other relevant pharmacopeia.
Can evaluate laboratory data to identify potential trends or shifts in product performance.
Displays a basic understanding of the regulatory impact of method changes, specification updates, etc.
Reviews and verifies standard and solution preparation documentation as required.
Responsible for identifying and communicating the errors found in the documentation and testing.
Demonstrates cooperation and professionalism with all members of the BPI organization.
Shows strong verbal and written communication skills, an ability to work both independently and within the framework of a team, and multi-tasks to maximize efficiency.
Evaluates lab systems and processes. Provides recommendations for compliance, efficiency improvements, and cost savings.
Independently revises the necessary documents and processes to implement changes.
Mentors' junior chemists on intermediate level instrument troubleshooting and quantitative testing.
Provides training as applicable.
Demonstrates a willingness to take on additional responsibilities and learn new processes to meet business needs.
Proficient in a wide range of routine testing tasks.
Displays sound judgment and consistency in decision making and problem-solving processes.
Independently authors test methods and method validation protocols and reports with support from department management.