In-Process QC Analyst

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. Corden Pharma embraces fair hiring practices.

CordenPharma is a leading full-service contract development and manufacturing organization (CDMO) of active pharmaceutical ingredients (APIs), excipients, and pharmaceuticals Drug Products (DP) and packaging capabilities with > 2,600 employees across the world. Our services enable pharmaceutical and biotech companies to manufacture medicines with the ultimate goal of improving people’s lives.

Our network in Europe and the U.S. offers flexible and specialized solutions across five technology platforms: Peptides, Lipids, & Carbohydrates; Injectables; Highly Potent & Oncology; and Small Molecules. We strive for excellence in supporting this network and are committed to providing the highest quality products for the well-being of patients.

SUMMARY

Performs laboratory tests to determine chemical and physical characteristics or composition of solid and liquid materials for such purposes 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. Displays initiative in completing training, and the ability to train others. Displays a high level of attention to detail.

ESSENTIAL DUTIES AND RESPONSIBILITIES

Include the following. Other duties may be assigned.

• 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 use of 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

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.

QUALIFICATIONS

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

EDUCATION and/or EXPERIENCE

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.

LANGUAGE SKILLS

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.

MATHEMATICAL SKILLS

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.

REASONING ABILITY

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.

CERTIFICATES, LICENSES, REGISTRATIONS

None.

PHYSICAL DEMANDS

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

While performing the duties of this job, the employee is regularly required to work with hands; and talk or hear. The employee frequently is required to stand, walk, and sit. The employee is occasionally required to reach above shoulder height; climb or balance; stoop, kneel, crouch, or crawl; and taste or smell. The employee must occasionally lift and/or move up to 50 pounds. Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, depth perception, and ability to adjust focus.

WORK ENVIRONMENT

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

While performing the duties of this job, the employee is 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.

CORE COMPETENCIES

These are the specific areas of knowledge, skill and ability that are important for successful job performance. They must be job related and consistent with business necessity.

• 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

SALARY

Actual pay will be based on your skills and experience.

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