Current jobs related to Sr. Associate, QC Micro - Arcadia - Theragent Inc

The Senior Associate, QC Micro has a unique opportunity to play a key role in building of the QC Microbiology laboratory from ground up for a Cell and Gene therapy biotech startup. The Senior Associate, QC Micro will be responsible for participating in the day-to-day operation of CGMP compliant Quality Control Microbiology laboratory of Theragent Inc to include performing and providing support for functional aspects of the facility such as environmental and utility monitoring (EM), microbiological testing, media fills, water testing, and other activities that will support execution of testing for CGMP samples for in-process, lot release and stability samples in-house. This role will be responsible for documentation that is compliant with all applicable procedures, standards, and CGMP regulations. The QC Microbiology Laboratory is a highly controlled environment, where significant attention must be paid to written procedures, safety, and CGMP compliance. Schedules and completing testing on time error free are of paramount importance. The lab is equipped with highly sensitive and expensive instruments which must be handled with care.

• Perform environmental and utility monitoring of the cell and gene therapy production facility according to written procedures while fully gowned including operational monitoring and personnel monitoring during aseptic processing, and aseptic filling. Perform routine environmental monitoring, as needed to meet schedules.
• Read environmental and utility monitoring plates by counting microbial colonies. Fill out appropriate reports and forms contemporaneously and review data provided by Lab Associate. Perform microbial identification like gram stains, gene sequencing. Track all data and complete in a timely manner. Perform all activities in compliance with CGMP regulations.
• Perform other microbiology assays, including bioburden, endotoxin, etc.
• Support preparation of quarterly and annual reports, trend investigations, statements of quality, and other applicable reports.
• Support onboarding and qualification of laboratory equipment and GMP software systems.
• Assist with the generation of SOPs related to test methods and product lot release.
• Assist in drafting technical documents including test methods, validation documents, and deviations.
• Purchase all necessary supplies, needed for QC Microbiology and receive supplies, log-in and store appropriately following written procedures.
• Perform growth promotion analyses on all microbiological media lots received. Report results on appropriate forms and review results of Lab Associate.
• Perform laboratory and equipment cleaning, preventative maintenance and calibration on a regular basis as described in written procedures. Record all necessary information and maintain current, accurate, legible records of all work performed. Report problems to management.
• Ensure compliance with all quality requirements to meet audit standards and regulatory compliance.
• Maintain lab equipment, reagents inventory, and documentation to ensure accurate, timely, and cost- effective analysis of materials and products.
• Assist in training staff on methods and related SOPs.
• Analyze and summarize data into reports with attention to details.
• Support any improvements identified through investigations and audits.
• Perform sample management tasks, including labeling, shipping to external labs, inventory, and disposal of samples.
• Other duties as assigned by management.

Reports to: Supervisor, QC Microbiology

FLSA Status: Non-exempt

Location: Arcadia, CA

Knowledge, Skills & Abilities:

• Knowledge of CGMP, ICH, pharmacopoeia, and regulatory requirements for testing pertaining to the pharmaceutical industry is required.
• Experience in the qualification of cell therapy equipment a plus.
• Knowledge of pharmaceutical, manufacturing and laboratory systems and equipment.
• Working knowledge of Deviations, Change Controls, and CAPAs.
• Basic knowledge of Compendial (i.e., USP, EP, JP, etc.) requirements and standards.
• Strong knowledge of CGMP and ICH guidelines. Other regulatory agencies experiences preferred.
• Strong understanding of Microbiology related to drug substance or drug product manufacturing.
• Strong written and verbal communication skills.
• Excellent interpersonal and teamwork skills with experience dealing with all levels within the company.
• Willingness to collaborate internally and with clients while following regulations
• Strong multi-tasking ability in conjunction with proven organizational and record keeping skills.
• Ability to organize assigned tasks in a high paced environment and monitor tasks / assignments that may impact timely completion.
• Ability to effectively manage multiple tasks and activities simultaneously.
• Proficient computer skills in Microsoft Office Suite - Word, Excel, PowerPoint, and Outlook. Innate ability to learn new software, such as corporate intranet and enterprise business.
• Strong team player, able to meet deadlines and change priorities.

• Bachelor’s degree in Microbiology, Molecular and Cell biology, Biology or related field required. In lieu of this requirement, work experience may be considered.
• At least 4 years of work experience in the Pharmaceutical, Life Sciences industry with CGMP, GLP.
• Experience with problem solving methods such as DMAIC or other similar Root Cause Analysis Tools.
• Experience with electronic Laboratory Information Management Systems (LIMS).
• Experience with relevant microbiology laboratory equipment and software.

• Primarily office environment but will be required to enter laboratory or GMP process areas donning proper gowning / lab coats or PPE such as safety glasses and shoes.
• Clean room Manufacturing and Laboratory environment
• Must be able to read, write, and converse in English
• Occasional stooping, bending, stretching, pushing, pulling, reaching and/or lifting up to 25lbs.
• Ability to sit, stand, walk and move within workspace for extended periods.
• Ability to perform repetitive tasks including hand to finger manipulations, grasping, pushing and pulling.
• Ability to work safely and effectively when working alone or working with others.

Travel: Occasional. Less than 10%

This description outlines the basic responsibilities and requirements for the position noted. This is not a comprehensive listing of all job duties of position. Duties, responsibilities, and activities may change at any time with or without notice.

Theragent, Inc. is an equal opportunity employer and prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity or expression, national origin or ancestry, age, disability, marital status, and veteran status. All qualified applicants will receive consideration for employment.

Theragent, Inc. requires employees to be vaccinated against COVID-19. To the extent permitted by applicable law, candidate must be able to provide proof of full vaccination or receipt of the first dose of a two-dose COVID- 19 vaccine, or request an exemption due to a medical reason, a sincerely held religious belief of practice, or pregnancy, as of the first day of work, to be considered for a U.S.-based job.