About this roleROLE SUMMARY
The main responsibilities of an Environmental Compliance Technician I involve performing environmental monitoring of the Aseptic Processing Area (APA). Individuals will also perform activities outside of the cleanroom including the examination of environmental monitoring samples for the recovery of microbial growth and the entry of data into a validated database. Sampling activities for this position includes viable surface and air monitoring, non-viable air monitoring and water sampling across the facility.
Individuals for this role should have strong leadership and interpersonal skills. Additionally, individuals should be respectful of others and be well respected by their peers. The individual should be comfortable working independently and be able to manage multiple activities occurring simultaneously. Lastly, individuals should have a basic understanding of microbiology, have a strong commitment to quality and be comfortable working in a laboratory environment.
ROLE RESPONSIBILITIES
Acquire proper knowledge and understanding of company and departmental policies pertaining to current Good Manufacturing Practices (cGMPs), Good Laboratory Practices (GLPs), safety, health and security.
Perform various sampling activities, including viable surface/air samples, non-viable air samples and facility water samples, on a daily basis throughout the aseptic processing area.
Required to actively demonstrate knowledge of practical laboratory skills, methodologies, and procedures. Employees must be capable of using standard laboratory equipment and able to examine microbiological survey samples for the absence or presence of microbiological organisms.
Must have mathematical reasoning skills and able to collect/ analyze data.
Maintain accurate and concise records with attention to detail.
Able to deal with frequent change, delays, or unexpected events.
When procedural deviations are noted, proper steps are to be taken to notify quality management. Ethical and integral work is required.
Able to listen and obtain clarification from supervisory staff as required. Must be capable of writing clearly and informatively. Capable of evaluating and presenting numerical data effectively.
Capable of completing tasks on time. Must be able to develop a plan or notify appropriate staff of when alternative plans are required.
Must be able to interact with management and non-management employees. Treat others with respect and consideration regardless of their status, position and personal or cultural differences.
Follow all safety and security procedures. Meet department safety objectives consistent with the job requirements.
Become qualified on aseptic gowning and technique.
Support quality functions involved in batch processing and GMP paperwork review.
BASIC QUALIFICATIONS
High School/GED and one-year general work experience, and/or training; or equivalent combination of education and experience.
PREFERRED QUALIFICATIONS
Associates degree or Bachelor’s degree in biology, microbiology, or related field and previous experience preferred.
California residents should review our Notice for California Employees and Applicants before applying.
Kindeva does not accept unsolicited assistance from headhunters or recruitment firms for any of our job openings. Any resumes or candidate profiles submitted to Kindeva employees—regardless of format—without a valid, signed agreement and an approved job order from an authorized signatory in Talent Acquisition will be considered the sole property of Kindeva. No fees will be paid in the event that a candidate is hired as a result of an unsolicited resume or referral.
Equal Opportunity Employer:
Kindeva Drug Delivery is an Equal Opportunity/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, gender, age, national origin, disability, Protected Veteran status, sexual orientation, or any other characteristic protected by federal, state or local law.
Do you see yourself as part of the Kindeva mission? Click Apply Now Today!