Quality Associate, Environmental Monitoring at OrganaBio

Miami, Florida, United States -

Full Time

Start Date

Immediate

Expiry Date

09 Sep, 26

Salary

0.0

Posted On

11 Jun, 26

Experience

2 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Environmental Monitoring, cGMP, Aseptic Gowning, Microbiological Testing, Cleanroom Cleaning, SOP Drafting, Data Trending, Deviation Investigation, CAPA, Laboratory Equipment Maintenance, Line Clearance, Quality Control, Cell Therapy Manufacturing, Microsoft Office, Sampling Techniques, Validation

Industry

Biotechnology Research

Description

POSITION SUMMARY Under the supervision of the Sr. Director, Quality Assurance and with guidance from the Associate Director, Quality Control and Analytical Development, the EM QC Associate will perform microbiological facility environmental monitoring (EM) support of sterile product manufacturing, to include sampling and testing of collected samples. This position will also perform cleanroom cleaning activities, including line clearance, and serve as the lead trainer for aseptic gowning qualification. This role may also support other microbiological test methods, equipment and laboratory support and maintenance, and assist with the drafting of SOPs, validations, protocols and reports to support cell therapy manufacturing operations. Organizes daily workload schedule and relevant resource requirements. Participates in authoring complex, explicit documentation for cell therapy manufacturing operations. The EM Quality Associate will also play a critical role in working collaboratively and training with cell therapy manufacturing associates in support of EM. This position is responsible for ensuring all activities are performed within an appropriate level of Current Good Manufacturing Practice (cGMP). Reasonable Accommodation Statement To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. Reasonable Accommodations may be made to enable qualified individuals with disabilities to perform the essential functions. Essential Functions: Performs routine and non-routine environmental monitoring (EM) of OrganaBio’s cGMP manufacturing facilities for total non-viable particulates, air viable particulates, and surface viable particulates per applicable standard operating procedures (SOPs). Performs cleanroom cleaning in preparation of GMP manufacturing and in accordance with established cleaning frequencies. Conducts line clearance activities in preparation of GMP manufacturing. May be required to perform static and dynamic process EM monitoring for cleanroom related activities Safely operates and maintains all EM testing and laboratory equipment including validation, routine calibration, and preventive maintenance in accordance with established practices, SOPs, and test methodologies. Coordinates and packages the shipment of collected samples to external laboratories. Responsible for documenting environmental and sampling deviations and reporting to area management. Responsible for leading the investigation and review of EM related quality events, including but not limited to EM excursions, deviations, non-conformances, and audit findings. Leads training and performs sampling for the gowning qualification and re-qualification programs for OrganaBio personnel. Reviews cleanroom EM data and assists in trending data and preparation of quarterly and yearly reports. Responsible for updating EM result spreadsheets, review of external and internal data reports, completion of EM forms, addresses corrections, and communicating excursions to management. Creates and revises standard operating procedures (SOPs), forms, and other EM and Quality documents. Trains new staff on EM equipment operation, maintenance, safety procedures, and SOPs. Trains new hires on cleaning methods for various ISO classifications in the Cleanroom. Maintains inventory levels of EM materials, components, and supplies as required for routine and non-routine environmental monitoring. Interacts closely with OrganaBio departments and external partners to ensure efficient, compliant, and timely execution of project activities. Participates in departmental meetings and attends other meetings as assigned. Drafts policies, processes, and procedures as needed in support of Quality operations. Drafts and executes validations as required in support of Quality operations. Reviews process labels as needed. Assigns product Lot numbers as needed. Reviews Certificate of Analysis (COAs) as needed. Drafts and/or reviews deviations, CAPAs, and complaints, and conducts investigations as needed. Non-Essential Functions: Other related duties as assigned. POSITION QUALIFICATIONS Competencies: Consistently sets a high standard for quality of work. Comfortable with working in a fast-paced and dynamic start-up environment. Ability to work flexible hours to meet business and/or customer needs. Excellent interpersonal, organizational, communication and listening skills. SKILLS & ABILITIES Education: Bachelor’s in microbiology or scientific related field or a combination of work experience and college coursework in the sciences a plus. Experience: Minimum of two years of relevant experience within a cGMP setting, preferably in the pharmaceutical, biotechnology, or cell therapy manufacturing facility. Experience with laboratory and aseptic manufacturing techniques. Cleanroom and GMP experience a plus. Computer Skills: Microsoft Office, including Word, Excel, PowerPoint, Outlook, and Teams. Familiarity with electronic documentation systems a plus. Other Requirements: Good organizational and time management skills; must be able to establish priorities and self-organize tasks. Ability to perform accurate detail-oriented work. Ability to trend and analyze data. Communication skills: foster open communication, active listening, good written and verbal communication skills. Ability to perform tasks per cGMP regulations including following detailed SOPs, maintaining training, deviation reporting and good documentation practices. Proven ability to meet deadlines, including time-sensitive tasks. Ability to use effective problem-solving techniques and make sound decisions. Ability to maintain confidentiality. Ability to perform environment monitoring testing in a highly accurate and reproducible manner.

Responsibilities

Perform microbiological environmental monitoring, including sampling and testing of particulates, within a sterile product manufacturing facility. Lead gowning qualifications, manage cleanroom cleaning activities, and author quality documentation such as SOPs and deviation reports.