Title: QC Associate Scientist
Location: Morris Plains, NJ (07950)
Duration: 6 Months 
Shift -(1 week Sun-Wed 7:30 AM-7:30 PM, then 2-week Sun-Tue 7:30 AM-7:30 PM)
(1 week Sun-Wed 3:30 PM-3:30 AM, then 2-week Sun-Tue 3:30 PM-3:30 AM)
(1 week Wed-Sat 7:30 AM-7:30 PM, then 2 weeks Thu-Sat 7:30 AM-7:30 PM)
(1 week Wed-Sat 3:30 PM-3:30 AM, then 2 weeks Thu-Sat 3:30 PM-3:30 AM)

Note - He have 4 different rotational shifts. When submitting the candidates, please mention the shift at the top of the resume

Job Description:
Under general direction, perform testing and other activities in functions supporting the Quality Control department (Micro/EM, QC Bio-assay and raw materials, as appropriate).
Major Accountabilities:
· Perform Bio-Analytical testing such as qPCR, Flow Cytometry, ELISA, cell count, cell viability.
· Perform micro/EM testing such as environmental monitoring, gram stain, sterility testing, endotoxin, and mycoplasma.
· Maintain controls and reference standards to support testing.
· Follows quality policies.
· Plan and schedule assigned activities.
· Generate trend reports.
· Review/approve data generated by other team members.
· Perform method qualification/optimization of methods as per appropriate protocols.
· Contribute to OOS/OOE investigations and deviation investigations.
· Support 5S and Lean projects.
· Identify potential improvements in project work.
· Interface with regulatory agencies during audits.
· Contribute to assigned projects.
· Knowledge of LabWare LIMS and/or other QC data systems.
· Maintain GMP/GLP quality systems.
In addition to these primary duties, provide coverage for all appropriate areas and test-ing.
Performs other job duties as assigned.

Key Performance Indicators:
· Deliver quality products and services on time to all customers, internal and external.

Ideal Background:
Education: BA or MS in chemistry, biochemistry, microbiology or other related science.
Languages: Fluent in English.
Experience:

• 2 - 5 years of experience in the pharmaceutical, biologics, microbiology, sterile manufacturing, or medical device industry.
• Knowledge of cGMP and an understanding of the concepts of GLP, good clinical practices and FDA guidelines, applicable state and foreign regulations, and standards routinely used in the industry (i.e. ANSI, ISO, etc.). Knowledge of microbiological and environmental monitoring, bioassay, and/or raw material test methods, as appropriate.
• Knowledge of LIMS systems.
• Ability to communicate clearly with a variety of individuals in various aspects of operations.
• Detail-oriented with expertise in problem-solving and solid decision-making abilities.
• Strong interpersonal skills which include a professional demeanor when interacting with personnel.
• Sound, practical and appropriate regulations    
• Strong written and verbal communication skills are essential.

Competency Profile:
Specific Professional Competencies: Indicate any other soft/technical/professional knowledge and skills requirements
Internal orientation
- Thorough understanding of cGMP requirements
- Good communication and organisational skills
- Ensure customer satisfaction and react to customer requests
- Is seen as a competent team player
Others
- Strong ability to work independently, compliantly and results driven.
- Strong analysis and decision-making skills surrounding documentation
- Pays attention to detail
- Able to proof work and identify non-standard format or wording, and errors within
documents 
 
At SPECTRAFORCE, we are committed to maintaining a workplace that ensures fair compensation and wage transparency in adherence with all applicable state and local laws. This position’s starting pay is: $ 30.00/hr.