Batch Record Review - Integra LifeSciences
Columbia, MD
About the Job
Changing lives. Building Careers.
Joining us is a chance to do important work that creates change and shapes the future of healthcare. Thinking differently is what we do best. To us, change equals opportunity. Every day, our colleagues are challenging what's possible and making headway to innovate new treatment pathways to advance patient outcomes and set new standards of care.
The Batch Record Reviewer will carry out manufacturing practices in a cGMP biotechnical facility.
The Batch Record Reviewer will carry out manufacturing practices in a cGMP biotechnical facility. The job involves reviewing, training, coaching Tissue Processing Technicians on batch records requirements in the Raw Material Department, Sheet and MicroMatrix Cleanrooms, and Component Preparation. The batch record reviewer will be the interface between operations and the Quality control team. The Batch Record review may also perform the tasks required as a Tissue Processing Technician if required to support production.
SUPERVISION EXERCISED
Tissue Processing Technician I, II and Lead
ESSENTIAL DUTIES AND RESPONSIBILITIES
+ Review Batch history records prior to being submitted for quality review
+ Provide feedback to Supervisor and Lead on:
+ Individual Tissue Processing Technician batch record performance
+ Recommend disciplinary action if required
+ Tissue Processing Technician Mid-year and Annual performance review input
+ May also perform duties of Tissue Processing Technician and Tissue Processing Technician II
+ Make suggestions that would improve the batch record review process or material processing
+ Keep track of the batch record review yield and work with engineering and the CI manager for process improvements.
+ Perform other tasks as needed
DESIRED MINIMUM QUALIFICATIONS
Education & Experience:
+ High school diploma or equivalent
+ 3 years GMP experience in an FDA regulated facility;
Required Knowledge, Skills, and Abilities
+ Good work ethic, dependable and punctual
+ Able to work well in both groups setting and independently
+ Flexible and adaptable to changing assignments
+ Working knowledge of GMP and ISO standards preferred
+ Must complete 90% of all training on the Tissue Processing Technician matrix
+ Satisfactory performance and performance reviews
+ Capable of leading and motivating Tissue Processing Technicians
TOOLS AND EQUIPMENT USED
Operation of specialty equipment (ex: lyophilizer, condenser, die press, etc.)
Integra LifeSciences is an equal opportunity employer, and is committed to providing equal employment opportunities to all qualified applicants and employees regardless of race, marital status, color, religion, sex, age, national origin, sexual orientation, physical or mental disability, or protected veteran status.
This site is governed solely by applicable U.S. laws and governmental regulations. If you'd like more information on your rights under the law, please see the following notices:
EEO Is the Law (https://www.eeoc.gov/laws/index.cfm) | EOE including Disability/Protected Veterans (https://www.eeoc.gov/eeoc/publications/ada_veterans_employers.cfm)
Integra LifeSciences is committed to provide qualified applicants and employees who are disabled veterans or individuals with disabilities with needed reasonable accommodations in accordance with the ADA (https://www.eeoc.gov/eeoc/publications/fs-ada.cfm) . If you have difficulty using our online system due to a disability and need an accommodation, please email us at careers@integralife.com or call us at 855-936-2666.
Integra - Employer Branding from Integra LifeSciences on Vimeo (https://player.vimeo.com/video/265760526)
Joining us is a chance to do important work that creates change and shapes the future of healthcare. Thinking differently is what we do best. To us, change equals opportunity. Every day, our colleagues are challenging what's possible and making headway to innovate new treatment pathways to advance patient outcomes and set new standards of care.
The Batch Record Reviewer will carry out manufacturing practices in a cGMP biotechnical facility.
The Batch Record Reviewer will carry out manufacturing practices in a cGMP biotechnical facility. The job involves reviewing, training, coaching Tissue Processing Technicians on batch records requirements in the Raw Material Department, Sheet and MicroMatrix Cleanrooms, and Component Preparation. The batch record reviewer will be the interface between operations and the Quality control team. The Batch Record review may also perform the tasks required as a Tissue Processing Technician if required to support production.
SUPERVISION EXERCISED
Tissue Processing Technician I, II and Lead
ESSENTIAL DUTIES AND RESPONSIBILITIES
+ Review Batch history records prior to being submitted for quality review
+ Provide feedback to Supervisor and Lead on:
+ Individual Tissue Processing Technician batch record performance
+ Recommend disciplinary action if required
+ Tissue Processing Technician Mid-year and Annual performance review input
+ May also perform duties of Tissue Processing Technician and Tissue Processing Technician II
+ Make suggestions that would improve the batch record review process or material processing
+ Keep track of the batch record review yield and work with engineering and the CI manager for process improvements.
+ Perform other tasks as needed
DESIRED MINIMUM QUALIFICATIONS
Education & Experience:
+ High school diploma or equivalent
+ 3 years GMP experience in an FDA regulated facility;
Required Knowledge, Skills, and Abilities
+ Good work ethic, dependable and punctual
+ Able to work well in both groups setting and independently
+ Flexible and adaptable to changing assignments
+ Working knowledge of GMP and ISO standards preferred
+ Must complete 90% of all training on the Tissue Processing Technician matrix
+ Satisfactory performance and performance reviews
+ Capable of leading and motivating Tissue Processing Technicians
TOOLS AND EQUIPMENT USED
Operation of specialty equipment (ex: lyophilizer, condenser, die press, etc.)
Integra LifeSciences is an equal opportunity employer, and is committed to providing equal employment opportunities to all qualified applicants and employees regardless of race, marital status, color, religion, sex, age, national origin, sexual orientation, physical or mental disability, or protected veteran status.
This site is governed solely by applicable U.S. laws and governmental regulations. If you'd like more information on your rights under the law, please see the following notices:
EEO Is the Law (https://www.eeoc.gov/laws/index.cfm) | EOE including Disability/Protected Veterans (https://www.eeoc.gov/eeoc/publications/ada_veterans_employers.cfm)
Integra LifeSciences is committed to provide qualified applicants and employees who are disabled veterans or individuals with disabilities with needed reasonable accommodations in accordance with the ADA (https://www.eeoc.gov/eeoc/publications/fs-ada.cfm) . If you have difficulty using our online system due to a disability and need an accommodation, please email us at careers@integralife.com or call us at 855-936-2666.
Integra - Employer Branding from Integra LifeSciences on Vimeo (https://player.vimeo.com/video/265760526)
Source : Integra LifeSciences
