Quality Control (QC) Analyst I

Colorcon®; Indianapolis (IN); On-site; USD 55,000 - 75,000; Full time

Benefits offered by this job

All employees bonus program

Three medical plans

100% company-paid Dental Insurance for

Optional Vision Coverage

Fitness and Wellness Programs

Employee Assistance Programs (EAP)

CSR Groups

Parental Leave

Tuition Reimbursement; up to $8,000/yr

401(k) Company Matching

Paid Time Off

Paid Holidays

Job summary

Colorcon is seeking a QC Analyst I to join our Indianapolis manufacturing facility. You will perform analytical testing on raw materials, intermediates and finished products, ensuring quality and compliance with cGMP.

This is an on-site, hands-on laboratory role requiring collaboration with operations and reporting to the Quality Manager. The position calls for a Bachelor's degree in a physical science (or 3 years of QC lab experience without a degree), strong analytical skills, and proficiency

Qualifications

• Bachelor’s degree preferred; three years in a QC analytical lab required without a bachelor’s degree.
• Experience with analytical chemistry, instrumentation, data compilation, and USP/NF procedures.
• Knowledge of cGMPs and adherence to regulatory requirements.

Responsibilities

• Analyzes materials and products by physical, chemical and instrumental techniques per procedures.
• Maintains laboratory inventory and calibrates equipment as needed.
• Submits accurate analytical reports and communicates out-of-spec results.
• Reviews coworkers' work and uses Colorcon’s Oracle database to ensure records accuracy.
• Adheres to cGMPs and documents calibration, OOS investigations, and related activities.
• Sets priorities with supervision according to production schedules.
• Interdepartmental communication with operations regarding material evaluations.
• Performs special analyses and assists with investigations when required.
• Maintains lab housekeeping, safety and organization.

Skills

Analytical chemistry

Data compilation

cGMPs knowledge

Organizational skills

Communication skills

Technical writing

Decision-making

Education

Bachelor’s degree in a physical science

Tools

Oracle database applications

Job description

Colorcon® is a world leader in the development, supply and technical support of formulated film coating systems, modified release technologies, specialty excipients and functional packaging for the pharmaceutical, nutritional, and animal health industries. Our best-in-class products and technologies are complemented by our extensive formulation experience, application data and value-added services to support all phases of solid oral dose design, development, and manufacture.

Our focus on market issues and technology development has earned Colorcon an international reputation as a pharmaceutical supplier of choice. That reputation is based on superior product quality, unparalleled technical support, extensive regulatory assistance and reliable supply from multiple locations, with our Global Headquarters located in Harleysville, Pennsylvania.

Colorcon has 26 technical service laboratories globally and more than 2100 employees exclusively dedicated to its customer base.

We are a successful company thanks to our diverse workforce and global reach. We believe that our operating principles define our culture, values and organizations and are key to achieving our mission and vision, strategies and goals.

Platinum Rule:

We treat others the way they want to be treated

Empowerment:

We trust our colleagues with responsibility and decision-making

Keep Getting Better:

We create an environment for constant improvement, to be the best we can

Teamwork:

We embrace the value of collaboration; work together to exceed what is possible as individuals

Customer Focus:

We put our customers’ needs at the heart of everything we do

Global Respect:

We are citizens of a diverse world and behave with respect for the communities in which we operate

Our People Enjoy a Wide Offering of Employee Benefits, including but not limited to:

• All employees are eligible to participate in our company-wide bonus program
• Employees have the choice between three medical plans
• 100% company-paid Dental Insurance for all employees and their qualifying dependents
• Optional Vision Coverage
• Fitness and Wellness Programs
• Employee Assistance Programs (EAP)
• Corporate Social Responsibility Groups (CSR)
• Parental Leave
• Tuition Reimbursement; up to $8,000 per calendar year
• 401(k) Company Matching
• Paid Time Off
• Paid Holidays

Colorcon is committed to maintaining a diverse workforce and an inclusive and equitable work environment. This includes all employment-related decisions and business dealings on the basis of race, color, ethnicity, national origin, age, sex, sexual orientation, religion, disability, veteran status, or any other legally protected status.

The QC Analyst I is responsible for determining quality of raw materials, intermediates and finished products using analytical methods and procedures as required. This position reports to the Quality Manager and works mainly the QC laboratory. The QC Analyst I performs numerous chemical assays using sophisticated instrumentation and interpret results with some supervision and must be able to observe proper procedures to ensure quality of finished goods and raw materials. The QC Analyst I is also responsible for meeting all other tasks assigned for their goals set by the Quality Manager.

Responsibilities & Duties

• Analyzes raw materials, intermediates and products by physical, chemical and instrumental techniques in accordance with established procedures with some supervision.
• Ensures the laboratory is in working order, which includes but is not limited to keeping inventory of chemicals and consumables needed in the lab and calibrating equipment when needed.
• Submits accurate, precise and complete analytical reports in a timely fashion; Communicates OOS results.
• Reviews the work of colleagues and other departments as needed.
• Exhibits a working knowledge of Colorcon’s Oracle database applications to maintain accuracy of records.
• Aware of cGMPs and cGLPs and maintains compliance with those regulations; Documents all activities associated with cGMP compliance (i.e. instrument calibration, OOS investigations etc.)
• Demonstrates the ability to set priorities, with some supervision, based on Operation’s schedules and deadlines.
• Interdepartmental communication with operations (Operators and Shift Leaders) concerning the use of materials evaluated.
• Performs special analyses and special project testing on a request basis as needed.
• Assists with OOS investigations as needed.
• Maintains good housekeeping, order, and safety in the laboratory.

Requirements

• Bachelor’s degree in a physical science, preferred.
• A minimum of three years in a quality control analytical lab required without a bachelor's degree.
• Preferred experience with analytical chemistry, instrumental analysis, data compilation, and USP/NF procedures and knowledge of cGMPs.
• Must have good organizational skills, decision-making skills, and communication skills.
• Strong technical writing skills.

Working Location

• This position is based on-site at Colorcon’s Indianapolis manufacturing facility.

Location:

3702 E. 21st St.

Indianapolis, Indiana, 46218

United States

Colorcon participates in E-Verify and will provide the federal government with your Form I-9 information to confirm that you are authorized to work in the U.S. If E-Verify cannot confirm that you are authorized to work, this employer is required to give you written instructions and an opportunity to contact Department of Homeland Security (DHS) or Social Security Administration (SSA) so you can begin to resolve the issue before the employer can take any action against you, including terminating your employment. Employers can only use E-Verify once you have accepted a job offer and completed the Form I-9.

E-Verify Works for Everyone

For more information on E-Verify, or if you believe that your employer has violated its E-Verify responsibilities, please contact DHS.