Danaher Corporation Specialist (Formulation - GMP) - Days in Coralville, Iowa
IDT is the leading manufacturer of custom oligonucleotides and proprietary technologies for genomics applications. Our work is complex and cutting-edge, and our team members are curious, creative thinkers who understand that good data drives smart decisions. At IDT, we realize that although science may be uniform, people are unique. We promote a culture where engaged people are motivated and have opportunities to achieve their full potential, as part of one global team.
IDT is proud to work alongside a community of nine fellow Danaher Life Sciences companies. Together, we’re pioneering the future of science and medicine, developing products that enable researchers in the fight to save lives.
Job Title: Specialist (Formulation - GMP)
Location: Coralville, IA
Shift: Days (Monday - Friday 7:00am - 4:00pm)
The Specialist (Formulation - GMP) position is responsible for handling products that fall outside of standard processing paths on an individual basis. This position will develop a plan and carry out necessary tasks to ensure the product meets customer expectations.
Job Specific Essential Functions:
Makes independent decisions regarding a product’s path based on individual attributes of the product and customer requirements
Makes pass/fail determinations based on QC testing and customer requirements
Documents procedures used for each product in custom software or by other controlled methods
Identifies effectively, the need for documentation/process changes, process deviations, product non-conformances and other occurrences that can indicate the ineffectiveness of quality and/or manufacturing systems
Creates work instructions, standard operating procedures (SOP) and oligo master records (OMR) that meet customer requirements
Adheres to customer specifics (in a strict manner) as well as general work instructions and SOPs
Performs training on new procedures
Troubleshoots and corrects problems that may occur during daily operations
Collaborates with members of team, as well as management, to ensure open communication and teamwork
Initiates PCOs when necessary for process and instrument changes
Programs, uses and maintains equipment used in the departmental tasks and processes
Participates in the validation of equipment used and processes performed in the group
Investigates customer complaints and obtains data for customer inquiries
Participates in customer and regulatory audits, as needed
Assists in utilizing metrics to monitor and communicate TAT and error rate to lab and upper management
Adheres to all departmental protocols, rules, and safety regulations and understands the requirements of ISO 9001, ISO 13485 and ISO 14001
Demonstrates behavior consistent with the Integrated DNA Technologies Core Values
Performs other duties as assigned
Associate’s degree in science related field plus 2 years of applicable lab experience required
Bachelor’s degree in science related field preferred
- Proficiency in a variety of PC software programs with strong working knowledge of Microsoft Office (and an emphasis on Excel) required
Proficiency with Excel, PowerPivot, JMP, or other statistical analysis software preferred.
Proficiency with Word and PowerPoint preferred.
Other Job Qualifications
Strong attention to detail
Uses aids and SOPs and departmental knowledge to make decisions about the proper production path per product
Ability to prioritize and organize workload to efficiently accomplish departmental goals
Ability to work in a team environment as well as independently
Ability to manage time and recognize responsibilities
Ability to communicate with peers and all levels of management
Ability to perform under stress when confronted with emergent, critical, unusual, or dangerous situations, or situation in which working speed and sustained attention are make-or-break aspects of the job.
Ability to perform a variety of duties, often changing from one task to another without loss of efficiency or composure.
Ability to maintain both a high standard of courtesy and cooperation in dealing with co-workers.
Ability to accept responsibility for the direction, control or planning of an activity.
Adaptability to situations requiring the precise attainment of set limits, tolerances or standards.
Ability to perform repetitive work or to perform continuously the same work, according to set procedures sequence or pace.
Exert 20-50 lbs. of force occasionally and/or 10-15 lbs. of force frequently
Constant (67%-100% of work day)
Reaching: extending hand(s) and arm(s) in any direction.
Using Fingers/Grasping/Feeling: writing or otherwise working, primarily with fingers rather than with the whole hand or arm as in handling. Applying pressure to an object with the fingers or palm and perceiving attributes of objects such as size, shape, temperature or texture by touch.
Talking: expressing or exchanging ideas by means of the spoken work- those activities in which they must convey detailed or important spoken instructions to other workers accurately, loudly, or quickly.
Hearing: perceiving the nature of sounds at normal range; ability to receive detailed information through oral communication, and to make fine discriminations in sound, such as when auscultating and percussing.
Repetitive Motion: substantial movements (motion) of the wrists, hands, and/or fingers.
Frequent (34-66% of work day)
Sitting: to assume a position in which the weight is largely supported by the buttocks, usually with the body vertical and the thighs horizontal.
Standing: maintaining an upright position.
Walking: moving about on foot to accomplish tasks.
Lifting: raising objects from a lower to a higher position or moving objects horizontally from position to position.
Bending: bending body downward and forward by bending spine at the waist and/or bending leg; bending legs at knee to come to rest or kneel.
Pushing/Pulling: using upper extremities to press against something with steady force in order to thrust forward, downward or outward/using upper extremities to exert force in order to drag, haul or tug objects in a sustained motion.
Occasional (33% or less of work day)
- Climbing: stairs, stools, ramps, ladders.
Work requires close vision, distance vision, peripheral vision, depth perception and ability to adjust focus.
Ability to read pertinent printed material and distinguish colors.
Ability to accurately read measurements on equipment.
Ability to prepare and read written documentation; use of computer.
What We Offer:
Shift Differentials (Extra Compensation for less traditional shifts)
Generous Paid Time Off Accruals
16 Hours PAID Volunteer Time Off
10 Paid Holidays
Up to eight (8) weeks of 100% paid parental leave to eligible U.S. associates
401(k) with Company Match
Medical, Dental, and Vision Insurance Options
Integrated DNA Technologies (IDT) conducts drug screens and background checks on applicants who accept employment offers.
When you join us, you’ll also be joining Danaher’s global organization, where 69,000 people wake up every day determined to help our customers win. As an associate, you’ll try new things, work hard, and advance your skills with guidance from dedicated leaders, all with the support of powerful Danaher Business System (https://www.danaher.com/how-we-work/danaher-business-system) tools and the stability of a tested organization.
Danaher Corporation and all Danaher Companies require all US and Puerto Rico employees to be vaccinated against COVID–19 as a condition of employment, subject to reasonable accommodation as required by law.
Danaher Corporation and all Danaher Companies are committed to equal opportunity regardless of race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law. We value diversity and the existence of similarities and differences, both visible and not, found in our workforce, workplace and throughout the markets we serve. Our associates, customers and shareholders contribute unique and different perspectives as a result of these diverse attributes.The EEO posters are available here (https://www.dol.gov/agencies/ofccp/posters) .We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform crucial job functions, and to receive other benefits and privileges of employment. Please contact us at firstname.lastname@example.org to request accommodation. If you’ve ever wondered what’s within you, there’s no better time to find out.