In-Process QC Analyst - NIGHTS

About the role

CordenPharma is seeking a Chemist to join our Night Shift team. This position offers a 18% shift differential in addition to the base pay.

Responsibilities

• Runs standard and advanced analysis in-process, raw material, intermediate and final release samples in compliance with applicable quality systems to meet development and/or customer service needs
• Analyzes batches of drug substance and/or intermediates to be used in clinical or registration programs
• Handles potent materials per applicable procedures and training as needed
• Performs qualitative tests or quantitative assays on samples using techniques that vary from use of standard analytical equipment to highly modern and automated instrumentation
• Trains new chemists as needed
• Ensures that laboratory productivity and turnaround goals are met through timely completion and peer-review of laboratory testing
• Maintains laboratory equipment and materials to ensure efficient laboratory operation
• Performs equipment calibration, titrant standardization, and standard validation as required
• Maintains cleanliness and organization of lab by following safety, regulatory, and chemical hygiene policies, including GLPs, GMPs, and 5S practices
• Performs daily record keeping on LIMS and related systems and print labels
• Identifies, troubleshoots, and/or corrects problems with methods and instruments in QC Labs
• Successfully communicates these activities to appropriate individuals, teams, supervisors and/or managers
• Attends and participates in Technical Team meetings as appropriate
• Develops team skills through training and mentorship
• Facilitates and supports analytical technology transfers, including validation of analytical methods and procedures
• Participates in manufacturing site activities, such as troubleshooting and analytical problem resolving
• Manages the generation and accumulation of hazardous and non-hazardous waste

Qualifications

• Bachelor's Degree from four-year college or university in Chemistry or related science field and two years’ experience in a laboratory; or equivalent combination of education and experience
• Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions

Leadership & Budget Responsibilities

Demonstrates positive attitude. Supports a positive, healthy, and flexible work environment that encourages employees and coworkers to develop their full potential and expand their horizons.

Safety & Environmental Responsibilities

Every individual is personally responsible for the safety and environmental aspects of their activities in the workplace. Each employee is expected to perform their job duties in a safe manner utilizing all their knowledge, training, ability, and experience.

Core Competencies

• Strong math, reading, and comprehension skills
• Reviews raw data in Chromatography Data Systems and other computerized GMP Systems; reviews and audits entries in LIMS Systems
• Analytical skills and knowledge of general or organic chemistry
• Mechanical aptitude with lab equipment
• Supports Senior level QC staff with general lab duties
• Preforms basic methods on test samples
• Good communication skills and computer skills
• Commitment to QSHE Principles
• Ability to work closely with team members to a common goal
• Attention to detail
• Ability to work on 12 hour rotating shifts, night or day; weekends and holidays as required

Salary & Benefits

Actual pay will be based on your skills and experience. Benefits include 401(k) matching, accident plan, critical illness insurance, dental insurance, disability insurance, employee assistance program, flexible spending account, health insurance PPO/HSA, hospital indemnity plan, ID theft protection, life insurance, paid maternity/paternity leave, tuition reimbursement, wellness program, vacation, vision insurance, and more.

Equal Opportunity Employer

Corden Pharma provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state, or local laws.