Colorcon is a world leader in the design and development of specialty excipients for solid oral dosages for the pharmaceutical and nutritional industries. We deliver superior product quality, unparalleled technical support, extensive regulatory assistance, and reliably supply from multiple locations, with our Global Headquarters located in Harleysville, Pennsylvania.

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 we 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).
Tuition Reimbursement; up to $8,000 per calendar year.
401(k) Company Matching.
Employees earn up to 17 days of PTO in their first year.
Nine Paid Holidays, plus One Personal Holiday for employees to assign at their choosing.

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.

Position Summary
The QC Analyst I is responsible for determining the quality of raw materials, intermediates, and finished products using analytical methods and procedures as required. This position reports to the Quality Manager and is housed in the QC laboratory. Must be able to perform numerous chemical assays using sophisticated instrumentation and interpret results with some supervision. Must also be able to observe proper procedures to ensure the quality of finished goods and raw materials. The QC Analyst I is also responsible for meeting all other tasks assigned via their yearly 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.

Required Qualifications:

Requires a bachelor’s degree in a physical science, or a minimum of three years in a quality control analytical lab.
Prefer 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.

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.

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QC Analyst I