Supervisor, Quality Control Microbiology (Flex)

avidbio; Tustin (CA); On-site; USD 67,200 - 84,000; Full time

Benefits offered by this job

Health, dental, and vision insurance

401(k) matching

Paid time off

Job summary

Avid Bioservices in California is seeking a microbiology specialist to oversee testing in support of manufacturing within a GMP environment. You will write/approve protocols and reports, lead investigations, and drive continuous improvement in the QC Microbiology group.

The role focuses on environmental monitoring, aseptic techniques, and adherence to cGMPs, USP, EP, and Annex 1. Onsite, with a schedule Mon-Fri 3:00 PM–12:00 AM and OT as needed.

Qualifications

• B.S. in Microbiology or related field with 5+ years in a GMP microbiology lab.
• Experience with protocol/report writing and investigations for root cause and CAPA.
• Experience with growth promotion, bioburden testing, Gram staining, and colony morphology.
• Knowledge of cGMP, USP, EP, and Annex 1; working in controlled environments.

Responsibilities

• Perform DRs/OOLs/OOSs investigations and determine root cause and CAPA implementation.
• Lead continuous improvement projects including SOPs/Test Methods/Forms updates.
• Lead microbiological studies and write/approve protocols and study reports.
• Perform data review of environmental monitoring and prepare trend reports.
• Oversee microbiological tests such as bioburden, growth promotion, and Gram stain in QCM lab.
• Train employees on microbiological test methods and Global SOPs.
• Direct activities through reports; represent QCM in interdepartmental meetings.
• Perform other duties as assigned.

Skills

Investigations & CAPA

Protocol & report writing

Environmental monitoring data review

Aseptic techniques

Cross-functional collaboration

Education

B.S. in Microbiology

Job description

Looking to join a passionate team dedicated to developing and manufacturing life-saving biopharmaceuticals? Avid Bioservices is a leading clinical and commercial biologics CDMO focused on creating innovative solutions to meet the needs of our clients and improve patient outcomes.

Your Role:

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.

Key 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

Minimum Qualifications:

• 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

Position Type/Expected Hours of Work:

This role is a full-time onsite position. Days and hours of work are Monday through Friday, 3:00 PM - 12:00 AM unless otherwise stated by Supervisor. The employee must also have the ability to work overtime and/or weekends when necessary.

Compensation:

We offer competitive compensation packages for this role, including a base salary, performance-based bonuses, and comprehensive benefits such as health, dental, and vision insurance, 401(k) matching, and paid time off.

The compensation range for this role is $67,200 - $84,000 annually depending on experience and qualifications. Additionally, we offer opportunities for career growth and development as well as a supportive and inclusive work environment.

Who you are:

• 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.

Physical Demands & Work Environment:

In this dynamic role, expect a blend of regular activities like sitting, standing, and walking, with occasional physically engaging tasks such as lifting objects up to 25 pounds. The work environment might expose you to electrical shocks, toxic chemicals, vibrations, or loud noise levels occasionally. However, reasonable accommodations are available to enable individuals with different abilities to perform effectively, ensuring a supportive and adaptable work setting. Your visual acuity, including close, distance, and color vision, will be essential in navigating through the diverse day-to-day demands of this position.