QC Associate 2

Salary Range: 72000 to 82000 (Currency: USD) (Pay period: per-year-salary)

Responsibilities

• Maintain functioning QC Laboratory, including material ordering, inventory control, general housekeeping, and other duties 

• Perform Sample management related activities and support QC for stability pulls and testing 

• Perform transfer and distribution of samples for in-coming Non-GMP and GMP samples into QC Sample Submission and appropriate laboratory 

• Receive samples and track to completion of testing and filing of data packages 

• Send out samples to contract labs and track results/reports. 

• Perform routine and non-routine environmental monitoring (EM) of the GMP manufacturing facilities for total particulates, air viables, and surface viables. 

• Initiate and participate in the investigations of EM excursions and assess any potential impact on product quality. 

• Trending EM data and generating quarterly and yearly reports. 

• Perform routine sampling and testing of pharmaceutical water systems and gas systems. 

• Perform bioburden and endotoxin testing for product and in-process samples, stability samples and raw materials. 

• Perform analysis and data analysis of in-process samples, APIs, and stability samples using existing methods. 

• Support assay transfer, qualification and validation activities for clients’ specific methods as needed.

•  Author final reports for assay qualifications under supervision. 

• Maintain QC lab equipment and provide assistance, as needed, during equipment and facility qualification activities. 

• Interact closely with other departments to ensure efficient, compliant, and timely execution of project activities as needed. 

• Assist in investigation and review of GMP quality events, including but not limited to deviations, out of specification reports, and audit findings. 

Qualifications

• Minimum of B.S. degree in Microbiology or related discipline with ≥ 3 years of experience in environmental monitoring of GMP facilities. 

• Minimum of three (3) years of experience working within a GMP Microbiology Lab. 

• Preliminary knowledge of the theoretical and practical aspects of analytical methods utilized in microbiology labs including Bioburden, TOC, Endotoxin, Conductivity, Gram staining, and Microscopy 

• Ability to gown and gain access to cleanroom and utility areas. 

• Demonstrated understanding of USP, EP and FDA microbiology testing requirements. 

• Strong written and oral communication skills, proficient with Microsoft Office software 

• Support Microbiology staff members as needed.