Correct title: Sr. Associate QC
The Sr. Associate works both independently and with the team to perform routine and non-routine microbiological testing and microbiology laboratory maintenance functions, where necessary.
• Carry out responsibilities in accordance with the organization's policies, procedures, and state, federal and local laws.
• Ensure compliance with current Good Manufacturing Procedures (cGMP), USP, EU and other global regulatory requirements at all times.
• Follow directions properly, work cooperatively as an individual contributor and as a team member.
• Communicate effectively with QC peers, cross-functional peers and management.
• Assist in troubleshooting and solving problems that may come up in the day to day operation of the department.
• Participate in aseptic process qualifications, such as aseptic gowning and media fill reads.
• Perform Bacterial Endotoxin and Sterility Testing on in- process, stability and finished drug products.
• Perform microbial identification via polymerase chain reaction (PCR).
• Perform growth promotion testing of microbiological media.
• Perform mycoplasma testing via PCR.
• Perform microbial isolation techniques and perform Gram stain identifications.
• Send out samples to contract labs and track results/reports.
• Evaluate environmental/personnel monitoring samples and create NOEs for action levels.
• Performs general laboratory cleaning/wipe-down.
• Perform routine maintenance of lab equipments.
• Under the guidance of management, support special project work.
• Document laboratory test results on worksheets and forms utilizing Good Documentation Practices.
• Maintain lab inventory and order lab supplies and materials.
• Receives and stock test reagents, lab supplies and test media.
• Support continuous improvement projects related to QC
• Author and revise controlled documents such as Standard Operating Procedures and Controlled Forms. Author non routine Protocols/Validation Plans in support of projects.
• Assist with deviation, Investigations/CAPA's associated with Microbiological testing.
• Support data trending and tracking of results.
• Perform other duties as assigned.
EDUCATION / EXPERIENCE REQUIREMENTS:
• Requires Bachelor's degree in Microbiology, Biotechnology, Molecular Biology, or related discipline and minimum 5 years of experience working in a regulated manufacturing environment. Microbiology lab experience strongly preferred. An equivalent combination of experience/education is acceptable.
• Have a good understanding of USP, EP, JP, and FDA microbiology testing requirements.
• Understanding of and ability to apply the regulations associated with 21 CFR 210/211.
• Good knowledge of Microsoft Word and Excel.
• Responds to challenges and additional projects in an understanding, positive, and objective manner.
• Adaptable to dynamic conditions, work practices, and project timelines.
• Provide schedule flexibility when needed.
• Ability to multitask, priortize workload and interpret data accurately.
• Able to communicate effectively with GDPO functional areas and external agencies.
• Fosters teamwork and promotes an environment that motivates others to achieve our goals.
• The incumbent will be required to wear uniform/ PPE to work in the manufacturing or
• The incumbent may be required to stand and walk for extended amount of time.
• The incumbent may be required to work hazardous materials.