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