QC Technician (Bioburden/Endotoxin)

Sunday to Thursday morning shift 9-5:30PM  (MUST be flexible working weekends and holidays.)

OR

Monday to Friday Second shift 12-8:30PM  (MUST be flexible working weekends and holidays.)

 6-month contract – Extensions will depend on performance and business need
 

Manager's update 
 

• This is the QC micro group
• Experience with Endotoxin and bioburden testing
• Number of water tests and process tests
• Working in a Biosafety cabinet
• This is an entry-level position
• Any experience is a plus
• Aseptic technique required
• Endotoxin and bioburden testing is preferred
• Biology or related lab science degree
• Over 5 years of experience is overqualified
• 0 to 3 years of experience will be great
• Most of the work is Endotoxin and bioburden testing
• Good communication skills
• LIMS experience
• Sample management is a plus
• A master’s degree is overqualified
• Local candidates are preferred
• An animal experience with a biology degree will work
• An associate's degree will work with good experience 

The Primary function would be to :

• Perform micro 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/or 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:

• BS in Biology or other life science required

What are the top 3-5 skills requirements should this person have?

• QC Micro experience- -Hands- on experience with lab testing and EM.
• 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.
• 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?

• 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
• This job requires to standing for long periods of time