Supervisor, Quality Control Microbiology (Flex)
About The Position
Oversees microbiological testing in support of Avid manufacturing processes within a GMP biopharmaceutical manufacturing organization. Writes and/or approves protocols and reports to support various microbiological studies. Leads microbiological/environmental monitoring investigations to determine root cause and corrective action. Assists in the preparation of environmental monitoring trending reports. Identifies and leads continuous improvement opportunities in the QC Microbiology group. Promotes awareness of aseptic techniques and procedures used in the microbiology lab. Ensures compliance to the internal policies and procedures, applicable regulatory guidelines, and cGMPs.
Requirements
- B.S. in Microbiology or related field with a minimum of 5 years of experience in a GMP facility working in a Microbiology lab.
- Experience in performing the following tasks on a routine basis: Protocol and report writing; Investigations to determine root cause and corrective action; Growth promotion testing; Bioburden testing of water systems, raw materials, in-process materials/components, and finished product; Gram Staining and experience with colony morphology; Basic microbiological techniques used in the microbiology lab to prevent contamination and cross contamination; Enumeration and sterility testing of spore strips/discs; Knowledge of aseptic techniques and behavior
- Must have knowledge of cGMP and should have necessary skills working in controlled environments
- Working knowledge of USP, EP, and Annex 1
Nice To Haves
- You have a "bring it on!" team player approach and an unshakable positive attitude, always ready to tackle anything that comes your way.
- Your written and verbal skills are out of this world, and you communicate with clarity and confidence.
- You have exceptional multitasking skills and an unparalleled attention to detail that ensure the smooth running of everything.
- You are a master at building relationships, capable of establishing connections with anyone, be it team members, clients, vendors, or suppliers.
Responsibilities
- Perform DRs/OOLs/OOSs investigations and determine root cause and implementation of CAPAs
- Lead continuous improvement projects including reviewing SOPs/Test Methods/Forms to update existing procedures and ensure compliance
- Lead various microbiological studies and write and/or approve protocol and reports for the study
- Perform data review of environmental monitoring and prepare environmental monitoring data trending reports
- Oversees a variety of microbiological tests such as bioburden, growth promotion, and gram stain for samples submitted to the QCM lab
- Train employees on microbiological test methods and Global SOPs
- Assist in various other functions as deemed necessary to maintain a state of compliance
- Directs activities of functional areas through direct reports.
- Represent QCM in interdepartmental meetings
- Perform other duties as assigned
Benefits
- health, dental, and vision insurance
- 401(k) matching
- paid time off
- performance-based bonuses
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
