Quality Control Manager - ChemRite

Job Description

Job Description

ChemRite CoPac is looking for a Quality Control Manager responsible for supporting a GMP-regulated liquid blending and filling manufacturing operation that provides contract packaging, blending, and filling services for OTC, cosmetic, and specialty chemical products. ChemRite CoPac partners with customers to manufacture high-quality liquid products across a variety of package types while maintaining strict adherence to FDA, GMP, and customer-specific quality requirements.

The Quality Control Manager manages the daily activities and job functions of the personnel of the QC Department, the analytical laboratory, and the plant microbiological plan. The Quality Control Manager works closely with Quality Assurance leadership to ensure that all incoming raw materials, batch mixes, and finished goods meet established standards while maintaining adherence to the Quality Systems Manual (QSM), supporting customer audits, and driving continuous improvement in a fast-paced production environment.

Responsible for planning, coordination, and execution of QC activities across raw material testing, finished product testing, stability, method transfers, cleaning and process validations. Accountable for achieving QC targets and KPIs, managing budgets, and developing a high-performing, cross-trained QC organization with robust succession and backup coverage for critical roles.

Specific responsibilities include, but are not limited to:

• Manages the daily activities and job functions of the personnel of the QC Department, including resource planning and scheduling.
• Manage quality control testing on incoming raw materials, batch mixes, finished goods and stability, per established standards.
• Maintain proficiency on all QSM (Quality Systems Manual) procedures, and create and update QSM specifications (i.e., Raw Materials, Packaging Materials, Finished Goods, Test Methods, and Validations).
• Identify gaps and make necessary modifications to QC documents.
• Lead laboratory investigations, deviations, OOS/OOT investigations, and recommend corrective and preventive actions (CAPAs)
• Leads project management of laboratory activities, ensuring alignment with manufacturing schedules, regulatory commitments, and product launch timelines.
• Ensures accurate documentation, review, and submission of raw data and results.
• Ensures data integrity and compliance through robust data review
• Support and sustains a continuous audit readiness program to ensure inspection-ready state at all times for customer audits and governmental agency inspections.
• Complete accurate documentation for tests, inspection results, and defects related to chemical raw materials, packaging materials, or finished packaging.
• Maintains SDS files.
• Orders all lab supplies and ensures all reagents and standards are current.
• Maintains the cleanliness of the QC labs, and retain room, and checks calibration of lab equipment per established standards.

Basic Qualifications – Required

• Bachelor’s degree in Chemistry or related field of study.
• At least 5 years of previous Quality Control experience in a cGMP and FDA-regulated manufacturing environment.
• Experience with various analytical instrumentation (HPLC, GC, FTIR, TOC, etc.).
• Strong written, verbal and interpersonal communication skills
• Strong attention to detail with consistent focus on data integrity and compliance
• Leadership capabilities such as building effective teams, problem solving and decision making
• Proficiency with Microsoft Word, Excel, PowerPoint
• A working knowledge of how to develop and validate analytical methods.
• A working knowledge of microbiological testing.
• A working knowledge of IQ/OQ/PQ.
• A working knowledge of how to plan and execute cleaning validations.
• A working knowledge of FDA regulations for the manufacturing of pharmaceuticals and OTC products.
• Provides clear direction and accountability for team performance.

Basic Qualifications – Preferred

• Reinforces safety culture and operational standards.
• Liquid fill manufacturing experience (e.g., hand soaps, sanitizers, cosmetics).
• Has a background with adjusting formulations to meet specifications.
• Bilingual in both English and Spanish.
• Demonstrates strong technical writing and communication skills relating to quality procedures.