Johnson Service Group, a nationally award-winning staffing firm, is looking to hire aQuality Control Associate, Microbiology for a biotech manufacturing company in Carlsbad, CA.
Direct Hire | Onsite | Pay range for this position is $27 - $32 per based on skills, education, experience, and other relevant qualifications.
Summary:
We are seeking a skilled and detail-oriented Microbiology Specialist to support the development and management of a comprehensive microbiology program. This role will oversee key areas such as aseptic fill/finish operations, environmental monitoring, gowning qualifications, and the implementation of compendial microbiology assays including endotoxin, bioburden, and sterility testing. The ideal candidate will ensure all activities align with current Good Manufacturing Practices (cGMP) and regulatory standards. Prior experience in aseptic processing, contamination control strategies, and drug product process validation is highly preferred.
Duties and Responsibilities:
Serve as a subject matter expert (SME) for Microbiological assays and methods during internal/external audits, risk assessments, investigations, and client visits
Supports assay transfer, qualification, and validation activities for microbial based assays or clients' specific methods
Author, revise, and review Quality Control (QC) standard operating procedures (SOPs) and assay qualification protocols and reports
Perform analysis on in-process samples, APIs, raw materials, and stability samples using existing methods
Perform routine and non-routine environmental monitoring (EM) of GMP and GLP manufacturing facilities for total particulates, air viables, and surface viables.
Initiate and participate in the investigation of environmental monitoring excursions and assesses potential impact on product quality
Support a Gowning Qualification Program for all manufacturing and QC personnel
Perform routine monitoring of pharmaceutical water and gas systems
Maintain QC lab equipment and provide assistance, as needed, during equipment and facility qualification activities
Assist in trending EM data and generate quarterly and yearly reports
Participate in inspection readiness activities
Interact closely with other departments to ensure efficient, compliant, and timely execution of project activities
Provide assistance as needed to maintain a functioning QC Laboratory, including material ordering, inventory control, general housekeeping, and other duties
Assist in investigation and review of GMP quality events, including but not limited to deviations, non-conformances, and audit findings
Operate at a consistent and exemplary level of efficiency, producing high quality and accurate results with a client driven focus
Safely operate laboratory equipment in accordance to established practices and SOPs
Assist in training of additional team members
Under minimum supervision, support special projects as needed
Operates to the highest ethical and moral standards.
Adheres to quality standards set by regulations and Argonaut Manufacturing Services policies and procedures
Communicates effectively with supervisors, staff, and clients
Participate in projects within a team and as an individual
Support continuous improvement projects related to QC
Multi-task, prioritize workload, document properly and interpret data accurately
Follow laboratory safety requirements to promote a safety-first culture
Education and Experience Requirements:
Combination of Undergraduate courses and on-the-job experience in Microbiology or a related discipline (e.g., biology, chemistry, or biological sciences)
Minimum three (3) years' experience in Quality Control and environmental monitoring of GMP facilities
High intelligence and problem-solving skills
Excellent oral and written communication and listening skills
High level of personal and professional integrity and trustworthiness with a strong work ethic and the ability to work independently with minimal direction
Experience in a growth-oriented, cGMP contract manufacturing organization with a focus on compliant execution of business is preferred
General knowledge of one or more of compendial methods such as: Bioburden, Endotoxin, Growth Promotion, Sterility, and other microbiological methods
Knowledge in environmental excursion investigations, root cause analysis, out of specifications, and knowledge of cleanroom practices is preferred
Direct experience with endotoxin, bioburden, and growth promotion methodologies. Experience in sterility testing is highly desired
Experience with transfers and qualification/validations of large molecule focused analytical methods
Must have experience with Microsoft Office applicationsExperience with quality software and 21 CFR 11 applications preferred
#D800
** Johnson Service Group (JSG) is an Equal Opportunity Employer. JSG provides equal employment opportunities to all applicants and employees without regard to race, color, religion, sex, age, sexual orientation, gender identity, national origin, disability, marital status, protected veteran status, or any other characteristic protected by law.
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