Sr. QC Associate - Direct Material

We are seeking for an experienced Sr. QC Associate Direct Material (raw material) to support direct material validation and testing.  In this role the associate will apply knowledge of good manufacturing practices and good laboratory practices on a daily basis. Calibrate and maintain laboratory and instrumentation equipment. Revise and update standard operation procedures. Develop and/or optimize testing methods and troubleshoot testing methods. Maintain laboratories in audit ready and cGMP compliant manner and participate in audits. Compile data for documentation of test procedures and prepare reports for internal and regulatory submissions. Review and evaluate data for conformance to specifications/reports. Investigate anomalous data. Use state-of-the-art techniques to evaluate and implement new techniques and technologies. Maintain validation program for QC laboratory analytical instruments. Evaluate and trend data and discrepancies. Provide ongoing training and process improvements. Lead product operations with special projects. Support audits as a subject matter expert. 

The Opportunity

• Validation & Documentation Leadership – Creates, reviews, and approves validation documents while providing process and equipment knowledge, training, and day-to-day support to QC partners

• Operations & Problem Resolution – Monitors equipment and processes to identify and resolve issues, troubleshoots complex assay and equipment problems using advanced techniques, and identifies functional improvements

• Laboratory Testing & Analysis – Performs microbiological and chemical testing at all complexity levels, conducts lab investigations, manages environmental monitoring data, and evaluates new techniques and technologies

• Technical Expertise & Training – Serves as a subject matter expert and liaison across departments, trains analysts in basic to complex laboratory techniques, provides professional guidance, and represents QC during audits

• Safety, Compliance & Data Management – Ensures safety and security compliance (including TSA requirements where applicable), collects and generates data reports from electronic systems, and fosters a positive safety culture.

Supplementary Responsibilities 

• Act as supervisor designee in cross-site and/or interdepartmental meetings 

• Facilitate team meetings as required 

• Attend department meetings as required 

Who you are

• You possess a Bachelor’s Degree in Biology, Microbiology, Biochemistry, Chemistry or other relevant discipline with 7-8 years of related experience.

Knowledge, Skills, and Abilities 

• Demonstrate excellent organizational skills 

• Strong written and verbal communication skills, with demonstrated leadership in a large group 

• Computer skills- LIMS, Microsoft Word, Excel, Power Point, Visio 

• Ability to read and follow Standard Operating Procedures

• Work under limited direction and guidance Ability to invest time, as required, to expedite or complete assignments or projects. This shall include working non-standard hours such as evenings and weekends as necessary. 

• Demonstrate strong spreadsheet, word processing and database skills necessary to process and present technical data in a clear and concise manner. 

• Ability to read, interpret, and troubleshoot technical data Ability to use discretion and good judgment in making decisions including the ability to know when to refer a problem to senior level staff. 

• Demonstrate excellent written and verbal communication skills 

• Demonstrate strong presentation skills including the ability to prepare and deliver professional presentations to external business interests. 

• Ability to work in a fast pace environment with high volume testing schedules 

• Experience in chemical testing assays 

• Experience with electronic systems used in laboratories 

• Ability to multitask and manage time effectively 

• Knowledge of laboratory safety procedures 

• Experience working in GMP environment 

• Experience speaking to auditors 

Work Environment/Physical Demands/Safety Considerations

• Work in office and laboratory environment 

• Lif