QC Analyst

CordenPharma is a leading full-service Contract Development and Manufacturing Organization (CDMO) specializing in active pharmaceutical ingredients (APIs), excipients, drug products (DPs), and packaging. With around 3,000 employees worldwide, we help pharmaceutical and biotech companies manufacture medicines with the ultimate goal of improving people’s lives. Our network, spanning Europe and the U.S., provides flexible and specialized solutions across six technology platforms: Peptides, Lipids & Carbohydrates, Injectables, Highly Potent & Oncology, Small Molecules, and Oligonucleotides.

About the role

Performs all technician tasks accurately and efficiently without supervision. Initiates expert technical advice to customers and completes all tasks in the Technician Training manual. Maintains a high level of housekeeping and attention to detail.

Responsibilities

• Run routine samples of raw materials, intermediates, and final products.
• Test special request samples from plants, tech center, or process chemists.
• Perform equipment calibration, titrant standardization, and standard validation as required.
• Identify and correct problems with instruments in QC lab.
• Identify and communicate problems and solutions related to process, procedure, and materials to QC Chemist.
• Research and take corrective action on anomalous test results.
• Maintain cleanliness and organization of lab by following safety, regulatory, and chemical hygiene policies including GLPs and GMPs.
• Perform daily record keeping on SAP and LIMS, enter status changes for raw materials, initiate incident reports, and issue approval-for-use tags.
• Responsible for properly managing the generation and accumulation of hazardous and non-hazardous waste.
• Attend and participate in QC Team meetings. Develop team skills.

Requirements

• Bachelor's Degree (BA) from 4-year college or university; or 1 year of related experience and/or training; or equivalent combination of education and experience.
• GMP and lab equipment experience preferred.
• Ability to read and interpret documents such as safety rules, operating and maintenance instructions, and procedure manuals.
• Ability to write routine reports and correspondence.
• Ability to speak effectively before groups of customers or employees of the organization.
• Ability to calculate figures and amounts such as discounts, interest, commissions, proportions, percentages, area, circumference, and volume.
• Ability to apply concepts of basic algebra and geometry.
• Ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists.
• Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form.

Skills

• Strong math, reading, and comprehension skills.
• 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 QEH&S Principles.
• Ability to work closely with team members to a common goal.
• Attention to detail.

Physical demands

• Regularly required to work with hands and 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.
• 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.
• Noise level in the work environment is usually moderate.

Schedule

Ability to work on 12 hour rotating shifts, night or day; weekends and holidays required.

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 Parental Leave.
• Tuition Reimbursement.
• Wellness Program.
• Vacation – Three Weeks 1st Year.
• Vision Insurance.