QC Associate Scientist – Bioanalytical & Microbiology

These are the shift specifics/requirements both will be on Wed-Sat AM shift (rotating 1 week Wed-Sat, 1 week Thu-Sat, 07:30-19:30).

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 manufacture, 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 Client operations. § Detail-oriented with expertise in problem solving and solid decision-making abilities. § Strong interpersonal skills which include a professional demeanor when interacting with Client personnel. § Sound, practical and appropriate regulations with regards to Client § 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