Associate Manager - Quality Control

Job Description

Job Description

FLSA Status: Exempt

Location: Derry, NH

Summary:

The Associate Manager, Quality Control is responsible for planning, executing, and overseeing quality control activities to ensure the continuous production and release of raw materials and finished goods that meet defined specifications and customer requirements. This role serves as a key member of the Operations organization with the authority to test, approve, and release materials in compliance with ISO, GMP, and company protocols.

This position is highly integrated with Production and maintains a strong shop-floor presence, ensuring quality is built into the process through SOP discipline, hygiene standards, and operational excellence.

Key Responsibilities:

• Primary responsibility for Quality Control Department (verification, review, approval & release), including Quality testing, as needed. Signs COA's Performs Quality functions related to shipping, as needed
• Key member of the Operations Team
• Accurately analyzes and performs chemical testing of FG, in-process batches, R & D samples (as needed) according to established standards.
• Follows continuous improvement practices and participate in cross-functional teams, which impact production, increase efficiency, solve problems, generate cost savings and improve quality systems
• Maintains proximity to the Production team, has presence on the shop floor, ensuring that all SOPs and procedures are followed, manages quality within the process (SOP discipline, plant and equipment hygiene, and other quality-critical protocols)
• Performs and is responsible for day-to-day operations of QC Laboratory, ensuring GMP practices are implemented, documented and sustained. Conforms to TRI-K required protocols, including housekeeping & hygiene
• Accurately maintains and updates Quality Control Databases, on a daily basis
• Responsible for approval and release of incoming raw materials, maintenance of database and related specifications. Work with Purchasing on receipt of RM and reporting of non-conforming RM
• Primary responsibility for aseptically pulling, labeling and properly storing retained and micro samples for testing and retention. Tracks, investigates and reports deviations from established Quality Control standards.
• Maintain & documents laboratory calibrations, according to SOP’s and Work instructions, following ISO and GMP protocols, be fully competent to understand PD Quality methods, Specifications & Analytical equipment
• Actively participates in all quality complaints investigations overseen by the QA/QMS Manager.
• Responsible for the laboratory environment including supply purchases, sterilization of bottles, general cleanliness, and maintenance of laboratory equipment. Follow safe laboratory guidelines and plant safety protocols
• Works with R&D and marketing to develop selling specifications and appropriate test methods for all new products.
• Reviews all testing methodologies periodically and proactively looks to improve the same. Manages discussions with customers on test method differences, etc.
• Reviews and approvals of all 3rd-party laboratories. Manages communication and service levels with external laboratories ensuring timely performance and cost efficiency.
• Prepare reports regarding the QC department, as needed
• Manages staff, investigates critical errors and initiates corrective actions prior to product release
• Signs off raw material quality and "good-to-use" status

Qualifications:

• Bachelor Degree in Chemistry, Biochemistry, Chemical Engineering, or Microbiology
• 5 Years of laboratory experience in QC, R&D, or University
• Working knowledge of all laboratory’s analytical equipment
• Ability to develop new analytical methods
• Familiarity with TRI-K's manufacturing processes and product recipes
  Good communication skills

Work Environment:

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions.

This is an environment with many interruptions. While performing the duties of this job, the employee may be occasionally exposed to work near moving mechanical parts, fumes or airborne particles and toxic or caustic chemicals. The noise level in the work environment is usually low.

Physical Demands:

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions.

Travel Requirements:

Occasional (NJ or Third-party partners)