In-Process QC Analyst - DAYS

Corden Pharma Colorado

16h•Onsite

About The Position

Performs laboratory tests to determine chemical and physical characteristics or composition of solid and liquid materials for quality control, process control, consistency, and accuracy. This role requires the ability to set up and follow procedures independently, maintain a high level of housekeeping, and demonstrate initiative in completing training and the ability to train others. A high level of attention to detail is essential.

Requirements

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.
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.
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.
Preform 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.

Responsibilities

Run 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.
May analyze 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 standard analytical equipment to highly modern and automated instrumentation.
Responsible for training new chemists as needed.
Ensures that laboratory productivity and turnaround goals are met through timely completion and peer-review of laboratory testing.
Ensures laboratory equipment and materials are maintained; and systems are understood and followed in a manner that facilitates efficient laboratory operation. Performs equipment calibration, titrant standardization, and standard validation as required.
Maintain 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.
Researches and takes corrective action on anomalous test results as required. Collaborates with method owners as necessary.
May attend and participate in Technical Team meetings as appropriate. Develops team skills through training and mentorship.
May facilitate and support analytical technology transfers, including validation of analytical methods and procedures.
May 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.

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