Job Overview
CMIC is seeking a detail-oriented QC Analytical Chemist to support our pharmaceutical manufacturing operations. This role is a hands-on, laboratory-based position focused on routine quality control testing to support batch release and stability programs.
The ideal candidate will have direct experience in a cGMP pharmaceutical QC laboratory, performing testing on solid oral dosage forms (tablets and capsules) and working within a fast-paced, production-driven environment.
Key Responsibilities:
Routine QC Testing
- Perform analytical testing of raw materials, in-process samples, and finished products
- Execute batch release and stability testing for solid oral dosage forms (tablets and capsules)
- Perform assay, dissolution, and impurity testing using established methods
Instrumentation
- Operate and troubleshoot analytical instruments including HPLC/UPLC, dissolution, GC, UV-Vis, and FT-IR
- Perform routine calibration, system suitability, and maintenance of laboratory equipment
Data Integrity & Documentation
- Accurately document and review analytical results in accordance with cGMP and ALCOA+ principles
- Maintain complete, audit-ready documentation in LIMS and laboratory systems
Quality & Compliance
- Participate in OOS, OOT, and deviation investigations, including CAPA support
- Ensure all activities comply with cGMP, FDA, and ICH regulatory requirements
- Support internal and external audits as needed
Collaboration
- Work cross-functionally with Quality Assurance, Manufacturing, and R&D to support production timelines
- Assist in training junior analysts as needed
Qualifications
Education
- Bachelor’s degree in Chemistry, Analytical Chemistry, or related scientific discipline (required)
Experience
- 6–8 years of direct, hands-on experience in a pharmaceutical QC laboratory within a cGMP manufacturing environment
- Demonstrated experience performing routine QC testing, including:
- Batch release testing
- Stability testing
- Solid oral dosage forms (tablets/capsules)
- Must have current or recent experience in pharmaceutical QC
Note: This role is focused on routine QC laboratory execution. Candidates with primarily analytical R&D, CRO/bioanalytical, or non-pharmaceutical backgrounds will not be considered.
Technical Skills
- HPLC/UPLC (required)
- Dissolution testing (required)
- GC, UV-Vis, FT-IR
- Experience with assay and impurity testing
- Familiarity with LIMS and chromatography systems (e.g., Empower)
- Solid understanding of cGMP, ALCOA+, and data integrity requirements
Core Competencies
- High attention to detail and strong documentation discipline
- Ability to work independently in a routine, high-throughput QC environment
- Strong problem-solving and troubleshooting skills
- Effective communication and teamwork
Working Conditions
- Laboratory-based environment with exposure to chemicals and specialized equipment
- Ability to stand for extended periods and lift up to 25 lbs.
- Flexibility to production schedules, including occasional overtime
This job description is not intended to be all-inclusive. Employees may be required to perform other duties as assigned by management.
Pay: $36.00 - $40.00 per hour
Benefits:
- 401(k)
- 401(k) matching
- Dental insurance
- Disability insurance
- Employee assistance program
- Flexible spending account
- Health insurance
- Health savings account
- Life insurance
- Paid time off
- Referral program
- Vision insurance
Application Question(s):
- Do you have 6-8 years working as a bench Chemist?
Work Location: In person
