Technician IV, QC

Boehringer Ingelheim Gainesville , GA 30501

Posted 5 months ago

Description:

Coordination and testing of potency and identity testing of final products and in process samples to ensure product meets government regulated titer standards through Ovoculture culture methodologies. Backup technician for all other egg titrations and other egg testing to meet government standards. Person will be responsible for scheduling and allocating eggs for the Egg team in preparation for testing. This includes ensuring that stability testing is completed according to internal policies, and all tests are completed per policies and procedures. Includes following all departmental standard operating procedures and standard methods for performing Quality Control assays, safety, testing documentation, and cleaning records.

As an employee of Boehringer Ingelheim, you will actively contribute to the discovery, development and delivery of our products to our patients and customers. Our global presence provides opportunity for all employees to collaborate internationally, offering visibility and opportunity to directly contribute to the companies' success. We realize that our strength and competitive advantage lie with our people. We support our employees in a number of ways to foster a healthy working environment, meaningful work, diversity and inclusion, mobility, networking and work-life balance. Our competitive compensation and benefit programs reflect Boehringer Ingelheim's high regard for our employees.

Duties & Responsibilities:

  • Coordinate the testing of Ovoculture culture potency and identity testing, HA, Extraneous Pathogens, and Inactivation testing ensuring that the schedule for testing, competition of testing is concluded per department needs. Team lead will be validated and qualified to perform all potency/identity testing of final and in-process samples for all viruses tested in eggs, plus inactivation, extraneous pathogens and HA testing. The testing will be conducted via Ovoculture culture methodologies. Team lead will be assigned specific egg testing to perform daily. Includes the ability to work with minimal supervision and make independent decisions. Responsible for wearing proper personnel protective equipment. Proper cleaning of the test areas or equipment following Quality Control guidelines and documentation of cleaning on appropriate cleaning records. Will be expected to capture test results and monitor trends of tests make some wording about trends with controls and trends with test result-your monthly meetings.

  • Assist in the preparation of test eggs for use in lab tests. This includes obtaining eggs for use (may require lifting), racking and candling of eggs. Daily candling of test eggs and recording findings. Monitoring associated lab equipment temperatures or conditions and documentation of readings.

  • Qualified backup technician for other USDA regulated testing included but not limited to Salmonella testing, various virus titration methods, Mycoplasma testing, bioburden testing, glassware and media preparation as time allows. Includes following standard operating procedures for all testing and safety procedures as well as following the same guidelines as the primary technician for all aspects of the testing. Also will be required to become validated with new testing controls and assist in times of high work load. Requires good communications skills, willingness and ability to work in a team environment.

  • Other requirements include: scheduling of testing, the ability to follow all standard working procedures and departmental and company regulations, USDA guidelines and properly perform testing according to government regulations, proper good laboratory record keeping, monitoring of samples during the testing, and proper documentation followed throughout the testing period. Entry of testing results into the LIMS system. Notification to management of any problems in testing and includes notification to other departments of test results. Responsible for wearing proper personnel protective equipment. Proper cleaning of the test areas or equipment following Quality Control guidelines and documentation of cleaning on appropriate cleaning records.

  • Certified as Key User for LIMS (program for tracking QC testing) for QC and production. Oversees all aspects of lab data, set up, update, and maintain static data, build and work with queries, and aid in data exportation. Troubleshoot lot creation issues, sample issues, and static data updates. Responsible for training new users from train new users on all aspects as needed. Participate and work with the LIMS team on any system updates including any testing that is required, provide feedback on issues and work with the team to update static data or procedures based on new versions of the system.

  • Some Holiday and weekend coverage required

  • Performs other duties as assigned.

May not own or have contact with other birds or poultry.

Requirements:

  • Associate Degree in Science Related Field

  • 5 years of laboratory experience in a biologics industry or related field. High School degree with at least 10 years of laboratory experience may be considered.

Preferred:

  • Associate Degree in Science related field with previous QC experience.

Desired Skills, Experience and Abilities:

  • Regular attendance is required to assure continuance of operations and care of animals.

  • Self-motivated. Ability to think ahead to next task. Ability to work well under time constraints.

  • Must be a team player.

  • Excellent computer skills and an in-depth knowledge of the Microsoft Office suite of products. .

  • Maintain professional working relations with all team members.

  • Attention to detail and ability to document work performed is required.

  • Excellent communication skills and the ability to develop a team environment.

  • Must have a clean driving record.

  • Has knowledge and ability to use aseptic technique.

  • Ability to properly use of standard and inverted florescent microscopes.

  • Has basic computer skills, detail orientated with the ability to maintain accurate and detailed records.

  • Good communication skills with the ability to write and follow written procedures precisely.

  • Ability to lift and carry dewar for 50ft

  • Ability to sit at microscope station for extended periods of time.

  • Ability to work in a team environment.

  • Willingness to learn underlying concepts of the position and apply knowledge in everyday procedures.

  • Ability to lift / push / pull 50 lbs. and carry it at least 10 feet.

  • Must be able to squat, bend, and stoop, as well as twisting and turning.

  • Able to stand on feet for extended periods of time.

  • Manual dexterity and visual acuity are important.

  • This position may require working weekends along with flexible shift hours.

Eligibility Requirements:

  • Must be legally authorized to work in the United States without restriction.

  • Must be willing to take a drug test and post-offer physical (if required)

  • Must be 18 years of age or older

Who We Are:

At Boehringer Ingelheim we create value through innovation with one clear goal: to improve the lives of patients. We develop breakthrough therapies and innovative healthcare solutions in areas of unmet medical need for both humans and animals. As a family owned company we focus on long term performance. We are powered by 50.000 employees globally who nurture a diverse, collaborative and inclusive culture. Learning and development for all employees is key because your growth is our growth.

Want to learn more? Visit boehringer-ingelheim.com and join us in our effort to make more health.

Boehringer Ingelheim, including Boehringer Ingelheim Pharmaceuticals, Inc., Boehringer Ingelheim USA, Boehringer Ingelheim Animal Health USA, Inc., Boehringer Ingelheim Barceloneta, LLC and Boehringer Ingelheim Fremont, Inc. is an equal opportunity and affirmative action employer committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender identity or expression; affectional or sexual orientation; disability; veteran or military status, including protected veteran status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.

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Desired Skills, Experience and Abilities: * Associate Degree in Science Related Field * 5 years of laboratory experience in a biologics industry or related field * Previous Quality Control experience preferred * Has knowledge and ability to use aseptic technique. * Ability to properly use of standard and inverted florescent microscopes. * Has basic computer skills, detail orientated with the ability to maintain accurate and detailed records, good communication skills with the ability to write and follow written procedures precisely, * Ability to lift, push, pull, and carry dewar for 50ft. * Ability to sit at microscope station for extended periods of time. * Ability to work in a team environment. * Willingness to learn underlying concepts of the position and apply knowledge in everyday procedures. * Must be able to squat, bend, and stoop, as well as twisting and turning. * Manual dexterity and visual acuity are important. * Must be able to stand on feet for long periods of time and work in a sterile environment. * Must be able to wear appropriate Personal Protective Equipment (PPE.) 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Technician IV, QC

Boehringer Ingelheim