Quality Control Chemist II

AmerisourceBergen; Columbus (OH); On-site; USD 60,000 - 100,000; Full time

Job summary

An innovative company is seeking a Quality Control Chemist II to join their team in a new chemistry lab. In this role, you will be responsible for method development, validation testing, and ensuring compliance with regulatory standards. You'll collaborate with various departments to maintain quality systems and improve processes. This position offers an exciting opportunity to contribute to the health sector, making a real difference in the lives of people and animals. If you are detail-oriented and passionate about quality in pharmaceutical manufacturing, this role is perfect for you.

Benefits

Medical insurance

Dental insurance

Vision care

Paid parental leave

Professional development resources

Mentorship programs

Volunteer activities

Qualifications

• 5+ years in a cGMP laboratory environment required.
• Experience in method development and validation essential.

Responsibilities

• Conduct method development and validation testing for repackaged products.
• Ensure compliance with FDA and regulatory requirements.

Skills

Good oral and written communication skills

Interpersonal skills

Attention to detail

Ability to work independently

Ability to handle multiple tasks simultaneously

Education

Bachelor’s degree in chemistry or related field

Tools

MasterControl

Electronic documentation management systems (EDMS)

Job description

Quality Control Chemist II

Apply locations USA > OH > Columbus > John Glenn

Time type: Full time

Posted on: Posted 3 Days Ago

Job requisition id: R253339

Our team members are at the heart of everything we do. At Cencora, we are united in our responsibility to create healthier futures, and every person here is essential to us being able to deliver on that purpose. If you want to make a difference at the center of health, come join our innovative company and help us improve the lives of people and animals everywhere. Apply today!

Job Details

We are building a new chemistry lab to test the products in our packaging. This Quality Control (QC) Chemist II role will be creating the required documentation needed for the lab in preparation for initiating in-house testing.

This QC Chemist II will focus on method development and validation testing, as required, of products repackaged at AHP. The QC Chemist II will also assist in troubleshooting methods and OOS investigations for the chemistry lab. As time allows they will also assist in stability and release testing, as necessary, and work closely with other departments within the Quality Unit to ensure drug product meets all standards.

• Ensure stability and release testing activities are compliant with FDA, DEA, and other regulatory body requirements as applicable. Ensure compliance with local and corporate policies and procedures.
• Perform method development and validation testing for AHP repackaged products.
• Perform troubleshooting and assist with OOS investigations.
• Perform stability and release testing for drug products in accordance with compendial and global requirements, as applicable.
• Develop, revise, and review standard operating procedures (SOPs), work instructions (WIs), and test method documents to ensure compliance with applicable compendia and regulations.
• Assist in the support of manufacturing operations including process validation, environmental monitoring, and utilities as applicable.
• Perform review and release of stability and release tests for compliance to SOPs and regulatory requirements and ensure data is reported accurately.
• Prepare lab reports as required.
• Assist with root cause investigations for quality incidents related to chemical analysis for stability and release tests.
• Maintain Quality System records and ensure completeness and accuracy.
• Coordinate with department management to identify and implement compliant process improvements.
• Clarify regulations, policies, and procedures to internal teams as applicable.
• Coordinate with departmental leaders to develop appropriate corrective actions resulting from investigations, internal audits, and facility inspections.
• Conduct follow-up checks on the effectiveness of corrective actions and perform other duties to support Quality Systems and Regulatory Affairs department as assigned.

Education:

• Bachelor’s degree in chemistry or related field required.

Experience:

• Five or more years’ experience within a pharmaceutical manufacturing (cGMP) laboratory environment.
• Working knowledge of pharmaceutical manufacturing requirements, Quality System principles (Documentation, Training, Investigations/CAPA, Change Control, etc), and global Quality Control regulations.
• Method development and validation experience.
• Experience with MasterControl or other electronic quality management system preferred.

Skills & Knowledge:

• Good oral, written, communication, and interpersonal skills.
• Ability to develop and maintain cooperative working relationships with others.
• Effectively interfaces with multiple levels of associates within the organization, including management and plant associates.
• Ability to work independently.
• Ability to handle a variety of tasks simultaneously.
• Attention to detail.
• Familiarity with concepts of electronic documentation management systems (EDMS).

Work Environment:

• The work environment characteristics described here are representative of those an associate may encounter while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions:
• General pharmaceutical laboratory, production, and warehouse facility. The noise level in the facility is moderate.

Physical & Mental Requirements:

• Physical activity requiring reaching, bending, kneeling, stooping, lifting, finger dexterity, grasping, feeling, repetitive motions, talking, and hearing.
• Ability to lift up to 50 lbs.
• Visual requirement is for close vision, distance vision, peripheral vision and ability to adjust focus.
• Associate is required to stand, walk (or otherwise be mobile).
• Ability to deal with stressful situations as they arise.

What Cencora offers

We provide compensation, benefits, and resources that enable a highly inclusive culture and support our team members’ ability to live with purpose every day. In addition to traditional offerings like medical, dental, and vision care, we also provide a comprehensive suite of benefits that focus on the physical, emotional, financial, and social aspects of wellness. This encompasses support for working families, which may include backup dependent care, adoption assistance, infertility coverage, family building support, behavioral health solutions, paid parental leave, and paid caregiver leave. To encourage your personal growth, we also offer a variety of training programs, professional development resources, and opportunities to participate in mentorship programs, employee resource groups, volunteer activities, and much more.

Equal Employment Opportunity

Cencora is committed to providing equal employment opportunity without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, age, disability, veteran status or membership in any other class protected by federal, state or local law.