Quality Control Associate, Microbiology

Job Description

Johnson Service Group is looking for a Quality Control Associate, Microbiology for a biotech manufacturing company in Carlsbad, CA.

The position is responsible for ensuring all activities are performed within an appropriate level of cGMP compliance. Previous experience with aseptic filling operations and controls and drug product process validation is highly desired.

Schedule: Monday - Friday Flexible start time between 6:00am and 9:00am with a consistent schedule. Overtime, weekends and holidays may be required. Exceptions to the schedule must be approved by the manager in advance.

Responsibilities and Duties

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 viable.

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

Perform Bioburden, Growth Promotion, Endotoxin, Gram Stain, Microscopy, TOC, Conductivity, and Nitrates testing

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

Communicate 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

Requirements and Qualifications

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 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 applications

Experience with quality software and 21 CFR 11 applications preferredCompany Description

Our people and culture make JSG a great place to work. JSG’s mission is to empower people, help our clients reach their goals, and hire motivated individuals.

Johnson Service Group, Inc. (JSG) is a North American leader in the staffing and consulting services industry, with 40 years of experience investing in people and companies. We are always looking for great people to join our team—we want to see your success here at JSG! We can be found locally in more than 30 offices throughout the United States and Canada. JSG continues to work diligently to offer our clients and candidates world-class service and diversified offerings to fit their evolving needs.

We offer medical, dental, vision, life insurance options, 401(k), weekly pay, and more.

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.

Full-time