Quality Control Microbiology Analyst job in Monroe
|Employer:|| Glenmark Pharmaceuticals Inc., USA|
|State:||North Carolina (NC)|
Glenmark is actively seeking two (2) Quality Control Microbiology Analyst II's to join the team in Monroe, NC. The QC Microbiology Analyst II supports the Quality Control group to maintain process optimization and manufacturing activities. The Microbiologist is responsible for performing activities in support of the microbiology, environmental monitoring, and utility testing programs, which includes microbiological product testing, monitoring of the manufacturing production area, and supporting quality initiatives. The individual routinely conducts monitoring, testing, SOP generation and revision, investigation and change control coordination, and implementation of new microbiological programs such as microbial identification.
Responsibilities include but are not limited to:
- Preparation of Revenue and Capex Budget as per spent analysis project.
- Ensure financial prudence in resource planning, allocation and manage within approved budgets while building best in class quality processes and systems at site.
- Maintain quality system controls to ensure no critical and major market complaints.
- Ensure that all statutory and regulatory compliance are regularly monitored and is in a state of compliance as applicable.
- Take appropriate steps to reduce wastages and losses in the analysis process and build improved efficiency
- Writes, revises, and reviews laboratory procedures.
- Performs required data analysis, compiles data and prepares results for review.
- Data review and trending to ensure integrity and adherence to standard operating procedures and cGMPs.
- Supports daily collection of utility and environmental samples, including water and steam sample collection.
- Compendial testing such as microbial limit test, growth promotion, endotoxin, TOC and conductivity.
- Monitoring samples, in-process product samples, raw materials, and environmental monitoring (EM) samples.
- Execution of complex microbiological methods such as gram-staining, and microbial identification to species.
- Perform preparation of reagents, materials, and equipment used in microbiological testing in sterile environments, such as HEPA hoods.
- Maintain accurate and complete test records.
- Help maintain inventory by reporting needed supplies.
- Maintain sample logs on a daily basis to ensure timely testing and tracking of all samples.
- Packaging and sending samples to contract laboratories.
- Maintain Instrument Usage and Calibration Logs based on instrument usage during the preparation and testing of samples.
- Maintain current knowledge of regulatory and industry standards, trends and advancements.
- Coordinates and processes departmental change controls.
- Preparation, review and approval of sampling matrix and hold time schedule.
- Conducts and communicates results of lab investigations when test results fall outside pre-established specifications (OOS).
- Coordinates and performs laboratory investigations.
- Assists in equipment and instrument qualification, calibration, and preventive maintenance, as assigned .
- Establishes good working relation with contract laboratories.
- Supports in the development of methods transfer and validation, troubleshooting, cross validation, IQ/OQ protocols.
- Supports activities regarding audits of suppliers and contract labs in support of vendor certification program.
- Conducts statistical evaluation of the manufacturing and inspection process and training QC staff.
- Assures laboratory databases are maintained and accurate.
- Ensures control of laboratory documentation (Raw Material COA, testing instructions, testing.
- Ensure that all equipment is calibrated.
- Bachelor's degree in Microbiology, or closely related scientific discipline.
- Degree in Microbiology is highly preferred.
- Minimum of three (3) years of laboratory experience.
- Pharmaceutical & FDA/GLP industry experience is preferred over academic laboratory experience.
Knowledge & Skills:
- Microbiology laboratory skills and knowledge, such as aseptic techniques, is required.
- Basic understanding of cGMPs, cGLPs, FDA regulations, and industry guidelines, as well as international regulatory guidelines.
- Ability to keep neat, accurate and complete records and logs.
- Must be proactive, results oriented, with a strong attention to detail.
- Self-starter with good work ethic and ability to work independently with minimum supervision and use good judgment, or as a contributing member of a team.
- Ability to manage multiple projects simultaneously, meet deadlines, and handle an ever changing, fast paced critical work environment.
- Strong organizational, analytical, troubleshooting and problem-solving skills.
- Ability to analyse details and perform structured decision-making on a daily basis.
- Excellent verbal and written communication.
- Must be able to read, write, and speak English.
- Strong interpersonal skills with ability to interact with all levels of personnel in a professional manner.
- Good computer skills with basic knowledge of Microsoft programs, particularly Outlook, Word, Excel, etc.
- Knowledge of LIMS (Laboratory Information Management System) is a plus.
- Good communications skills, front runner, GMP trainer.
- Will be an added advantage if the individual has worked in Regulatory environment.