QA Compliance Specialist - Energetic Workplace

Shift: Monday to Friday 8—4:30

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 Holiday 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 Abbvie 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