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Job Description
Description Details
on occasional coming in early or staying late.
Monday thru Friday availability will be needed during first few months of training. Some weekends or Vacation coverage needed, will know in advance.
No Masters Degree or Research candidates.
THIS IS A 1 YEAR ASSIGNMENT WITH THE POSSIBILITY OF EXTENSION - Extension may become a possibility at any time
due to business needs, however, no guarantee is provided.
The Primary function would be to :
• Performs routine Environmental Monitoring testing within a GMP environment.
• Performs Environmental Monitoring (EM) during a fill operation.
• Supports other lab associated functions. Perform test methods
as written to support product/material release. Effectively perform
a multitude of laboratory techniques with minimal error for which they will be trained on.
Understand, implement, and maintain GMP with respect to laboratory records, procedures, and systems in accordance with procedural requirements.
Accept responsibility to complete assigned tasks as committed.
Support investigation writers and approvers to gather data. Effectively perform a multitude of laboratory techniques with minimal error for which they are or will be trained on
• Writes or revises procedures with guidance.
• Works under the guidance of a supervisor but is able to manage
their own time to ensure timely completion of assigned duties
• Trends data to support trend reports.
• Should be willing to work on weekends and holidays.
Top Skills:
QC Micro experience- -Hands- on experience with lab testing and EM.
• Hands- on Aseptic Technique experience preferable.
• Hands- on working experience in Biosafety hoods preferable. Attention to detail while running assays/ tasks in the lab and while performing EM is required
• Should have good organizational skills, ability to prioritize workload and extremely thorough with excellent attention to detail.
• Should perform tasks with supervision guidance, taking responsibility for complying with GMP requirements. MUST be flexible working weekends and holidays.
Strong interpersonal / communication skills. Maintaining good
working relationships within and outside the department.
Adjusting quickly to new situations. Reprioritizing to meet
schedule demands in continually changing work environment.
Knowledge with the LIMS system, specifically entering results is
preferred
Nice to have:
Knowledge of applicable regulations and standards affecting
Pharmaceutical Products (e.g. USP, EP, JP pharmacopoeias, ICH guidelines, cGMP) is preferred.
GMP and/or Clean-Room experience
Clean-Room Gowning
Experience with cGMP documentation and record maintenance is
required
• Years of experience/education and/or certifications required:
o BS in Biology or other life science required
o Having less than 1 year of experience is acceptable.
• What are the top 3-5 skills requirements should this person
have?
o QC Micro experience- -Hands- on experience with lab testing
and EM.
o Attention to detail while running assays/ tasks in the lab and
while performing EM is required
o Should have good organizational skills, ability to prioritize
workload and extremely thorough with excellent attention to
detail.
o Should perform tasks with supervision guidance, taking
responsibility for complying with GMP requirements.
o MUST be flexible working weekends and holidays.
o Strong interpersonal / communication skills. Maintaining good
working relationships within and outside the department.
o Adjusting quickly to new situations. Reprioritizing to meet
schedule demands in continually changing work environment.
o Must be comfortable standing for most of their shift. Shuttling
between Client buildings is required. Also, must be flexible to
work (some) weekends and holidays (pre-scheduled).
• What is a nice to have (but not required) regarding skills,
requirements, experience, education, or certification?
o Knowledge of applicable regulations and standards affecting
Pharmaceutical Products (e.g. USP, EP, JP pharmacopoeias, ICH
guidelines, cGMP) is preferred.
o GMP and/or Clean-Room experience
Clean-Room Gowning
Experience with cGMP documentation and record maintenance is required
About Kyyba:
Founded in 1998 and headquartered in Farmington Hills, MI, Kyyba has a global presence delivering high-quality resources and top-notch recruiting services, enabling businesses to effectively respond to organizational changes and technological advances.
At Kyyba, the overall well-being of our employees and their families is important to us. We are proud of our work culture which embodies our core values; incorporating value, passion, excellence, empowerment, and happiness, creates a vibrant and productive atmosphere. We empower our employees with the resources, incentives, and flexibility that they need to support a healthy, balanced, and fulfilling career by providing many valuable benefits and a balanced compensation structure combined with career development.
Disclaimer:
Kyyba is an Equal Opportunity Employer.
Kyyba does not discriminate on the basis of race, religion, color, sex, gender identity, sexual orientation, age, non-disqualifying physical or mental disability, national origin, veteran status or any other basis covered by appropriate law. Minorities / Females / Protected Veterans /Veteran Spouses/ Individuals with Disabilities are encouraged to apply. All employment is decided on the basis of qualifications, merit, and business need."
Rewards:
Medical, dental, vision
401k
Term life
Voluntary life and disability insurance
Optional Pre-paid legal plan
Optional Identity theft plan
Optional Medical and dependent FSA
Work-visa sponsorship
Opportunity for advancement
Long-term assignment with opportunity for hire by client
SELECT AWARDS
An INC 5000 company for 10 years
Corp. Michigan Economic Bright Spots
Crain's Detroit Business Top Staffing Service Companies in Detroit
TechServe Alliance Excellence Award- IT and Engineering Staffing & Solutions
Best of MichBusiness winner in HR Wizards & Partnerships
Metro Detroit Elite Category: Recruitment, Selection & Orientation for 101 Best & Brightest
101 Best & Brightest Companies to Work for in Michigan
Date Posted: 01 May 2024
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