The Senior Quality Control Analyst conducts and validates various biological and chemical quality control (QC) assays. Performs various scientific analyses to evaluate the quality of raw materials, in-process materials, and finished goods and ensure compliance with established standards. Being a Senior Quality Control Analyst may be responsible for establishing specifications for conducting assays and writing standard operating procedures. Compiles, interprets, and documents statistical data from testing processes to either confirm compliance with established quality standards or identify deviations. In addition, Senior Quality Control Analyst typically requires a bachelor’s degree. Typically reports to a supervisor or manager. Being a Senior Quality Control Analyst contributes to moderately complex aspects of a project. Work is generally independent and collaborative in nature. Working as a Senior Quality Control Analyst typically requires 4 to 7 years of related experience.
Senior Quality Control Analyst Job Description Template
Our company is looking for a Senior Quality Control Analyst to join our team.
Responsibilities:
- Assists in performing validations;
- Reviewing test method results for conformity to specification and reporting on quality discrepancies;
- Monitor critical operating parameters for laboratory equipment and instrumentation;
- Processing non-conformances as needed;
- Timely reporting and analysis of stability results to support initial expiry setting and expiry extensions;
- Stability, Raw Material and Sample Management program/process continuous improvement;
- Liaison with Logistics/Materials Management and External Quality;
- Syncade Manufacturing Execution System (MES) raw material inventory module user;
- Collaborate with Contract Test Laboratories and other outside entities;
- Coordinate receipt, tracking, storage, shipment and distribution of Stability, Raw Material and In-process QC samples;
- Assist with internal audits;
- Occasional travel to Cambridge required (<5%);
- Support creation and revision of Raw material specifications and risk assessments;
- Support implementation of LabWare LIMS;
- Recognize, report, and document deviations from SOPs, test methods and specifications.
Requirements:
- A minimum of 5 years of biopharmaceutical experience with accountability for cGMP QC Operations and Product Quality in a manufacturing plant;
- Superb communications—both written and oral skills and “do-what-it-takes” attitude;
- ISO exposure and familiarity required; ISO 9001:2015 lead auditor certification is a plus;
- Utilizes strong organizational, interpersonal and communication skills to plan and accomplish goals;
- Ability to prioritize daily activities in order to meet internal and external customer needs in a fast-paced environment;
- Analytical Instrumentation Knowledge: HPLC/UPLC, Luminometers, Microplate Readers, and/OR UV/VIS is preferred but not necessary;
- Team-oriented approach to project management and problem resolution;
- Priority will be given to candidates with direct experience in Stability and Raw Materials;
- Bachelor’s degree required; preference given to candidates with advanced degrees and degrees in Chemistry or a biological science;
- Thorough knowledge of cGMPs, ICH, USP/EP/JP and global regulatory requirements;
- Knowledge of test procedures and instruments for stability and raw material testing program;
- Strong organizational skills;
- Highly collaborative team player who fosters open communication and facilitates mutual understanding and cooperation between all stakeholders;
- Prior experience with LIMS is a plus.