In-Process QC Analyst - DAYS

About the Role

Performs laboratory tests to determine chemical and physical characteristics or composition of solid and liquid materials for purposes such as quality control, process control, consistently, and accurately. Displays ability to set up and follow procedures independently as directed. Maintains a high level of housekeeping, initiative in completing training, and the ability to train others. Demonstrates a high level of attention to detail.

Responsibilities

• Run standard and advanced analysis on in-process, raw material, intermediate, and final release samples in compliance with applicable quality systems to meet development and/or customer service needs.
• Analyze batches of drug substance and/or intermediates to be used in clinical or registration programs.
• Handle potent materials per applicable procedures and training as needed.
• Perform qualitative tests or quantitative assays on samples using techniques that vary from standard analytical equipment to highly modern and automated instrumentation.
• Train new chemists as needed.
• Ensure laboratory productivity and turnaround goals are met through timely completion and peer-review of laboratory testing.
• Maintain laboratory equipment and materials; follow systems that facilitate efficient laboratory operation.
• Perform equipment calibration, titrant standardization, and standard validation as required.
• Maintain cleanliness and organization of the lab by following safety, regulatory, and chemical hygiene policies, including GLPs, GMPs, and 5S practices.
• Perform daily record keeping on LIMS and related systems and print labels.
• Identify, troubleshoot, and/or correct problems with methods and instruments in QC Labs; communicate these activities to appropriate individuals, teams, supervisors, and/or managers.
• Research and take corrective action on anomalous test results as required; collaborate with method owners as necessary.
• Attend and participate in Technical Team meetings as appropriate; develop team skills through training and mentorship.
• Facilitate and support analytical technology transfers, including validation of analytical methods and procedures.
• Participate in manufacturing site activities, such as troubleshooting and analytical problem resolving.
• Responsible for properly managing the generation and accumulation of hazardous and non-hazardous waste.
• Demonstrate a positive attitude and support a positive, healthy, and flexible work environment.

Requirements

• Bachelor's Degree from a 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.
• Ability to read, analyze, and interpret common scientific and analytical journals, financial reports, and legal documents.
• Ability to respond to common inquiries or complaints from customers, regulatory agencies, or members of the business community.
• Ability to write speeches and articles for publications that conform to prescribed style and format.
• Ability to effectively present information to top management, public groups, and/or boards of directors.
• Ability to apply advanced mathematical concepts such as exponents, logarithms, quadratic equations, and permutations.
• Ability to apply statistical concepts such as significant figures and analysis of variance.
• Ability to define problems, collect data, establish facts, and draw valid conclusions.
• Ability to interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables.

Skills

• 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.
• Support Senior level QC staff with general lab duties.
• Perform basic methods on test samples.
• Good communication and computer skills.
• Commitment to QSHE (Quality, Safety, Health, Environment) 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.

Physical Demands

• Regularly required to work with hands; talk or hear.
• Frequently required to stand, walk, and sit.
• Occasionally required to reach above shoulder height; climb or balance; stoop, kneel, crouch, or crawl; and taste or smell.
• Must occasionally lift and/or move up to 50 pounds.
• Specific vision abilities required include close vision, distance vision, color vision, peripheral vision, depth perception, and ability to adjust focus.

Work Environment

• Occasionally exposed to fumes or airborne particles, low levels of toxic or caustic chemicals, and outside weather conditions.
• The noise level in the work environment is usually moderate.

Benefits

• 401(k) matching - Corden Pharma will contribute 100% of the first 6% (100% vested after 2 years of service).
• 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 – Three Weeks 1st Year.
• Vision Insurance.