Quality Control (QC) Analyst I

Colorcon, Inc.; Indianapolis (IN); On-site; USD 52,000 - 64,000; Full time

Benefits offered by this job

Bonus program

Medical plans

Dental Insurance

Vision Coverage

Wellness programs

Employee Assistance Programs (EAP)

CSR Groups

Parental Leave

Tuition Reimbursement

401(k) Matching

Paid Time Off

Paid Holidays

Job summary

Colorcon, Inc. is seeking a Quality Control (QC) Analyst I for our Indianapolis, Indiana facility. The role involves determining quality of raw materials, intermediates and finished products using analytical methods within the QC laboratory.

Responsibilities include performing chemical assays, maintaining Lab operations, calibration, and timely reporting while ensuring cGMP compliance and proper documentation under the supervision of the Quality Manager.

Qualifications

• Bachelor’s degree in a physical science is preferred.
• Minimum of three years in a QC analytical lab (without a bachelor’s degree).
• Familiarity with USP/NF procedures and cGMPs preferred.

Responsibilities

• Analyze raw materials, intermediates and finished products using physical, chemical and instrumental techniques per established procedures.
• Maintain lab inventory and calibrate equipment as needed.
• Submit accurate analytical reports and communicate OOS results promptly.

Skills

Analytical chemistry

Instrumental analysis

Data compilation

cGMPs knowledge

Technical writing

Communication skills

Education

Bachelor’s degree in physical science

Tools

Analytical instruments

Job description

Quality Control (QC) Analyst I

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:

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 choicebetween 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 ResponsibilityGroups (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 maintaininga diverseworkforce and an inclusiveand 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 protectedstatus.

The QC Analyst I isresponsible for determining quality of raw materials, intermediates andfinished products using analytical methods and procedures as required. This position reports to the Quality Managerand works mainly the QC laboratory. TheQC Analyst I performs numerous chemical assays using sophisticatedinstrumentation and interpret results with some supervision and must be able toobserve proper procedures to ensure quality of finished goods and rawmaterials. The QC Analyst I is alsoresponsible for meeting all other tasks assigned for their goals set by the QualityManager.

Responsibilities &Duties

• Analyzes raw materials, intermediates andproducts by physical, chemical and instrumental techniques in accordancewith established procedures with some supervision.
• Ensures the laboratory is in working order, whichincludes but is not limited to keepinginventory of chemicals and consumables needed in the lab and calibratingequipment when needed.
• Submits accurate, precise and complete analyticalreports in a timely fashion; Communicates OOS results.
• Reviews the work of colleagues and otherdepartments as needed.
• Exhibits a working knowledge of Colorcon’s Oracledatabase applications to maintain accuracy of records.
• Aware of cGMPs and cGLPs and maintains compliancewith those regulations; Documents all activities associated with cGMPcompliance (i.e. instrument calibration, OOS investigations etc.)
• Demonstrates the ability to set priorities, withsome 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 projecttesting on a request basis as needed.
• Assists with OOS investigations as needed.
• Maintains good housekeeping, order, and safety inthe laboratory.

Requirements

• Bachelor’s degree in a physical science,preferred.
• A minimum of three years in a quality controlanalytical lab required without a bachelor's degree.
• Preferred experience with analytical chemistry, instrumental analysis, data compilation, and USP/NF procedures andknowledge 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

Colorconparticipates in E-Verify and will provide the federal government with your FormI-9 information to confirm that you are authorized to work in the U.S. IfE-Verify cannot confirm that you are authorized to work, this employerisrequired to give you written instructions and an opportunity to contactDepartment of Homeland Security (DHS) or Social Security Administration (SSA)so you can begin to resolve the issue before the employer can take any actionagainst you, including terminating your employment. Employers can only useE-Verify once you have accepted a job offer and completed the Form I-9.
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For moreinformation on E-Verify, or if you believe that your employer has violated itsE-Verify responsibilities, please contact DHS.