**Shift: Tuesday-Saturday 8-4:30**

**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.**

**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 mínimal 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 mínimal 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 experienceHands
- 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**:

- BS in Biology or other life science required
- Having less than 1 year of experience is acceptable.

**What are the top 3-5 skills requirements should this person have?**
- QC Micro experienceHands
- 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

**Job Type**: Contract

Pay: $32.00 - $34.50 per hour

Expected hours: 40 per week

**Benefits**:

- Commuter assistance
- Flexible schedule
- Health insurance
- Life insurance
- Paid time off

Schedule:

- 8 hour shift
- Day shift
- Monday to Friday
- Overnight shift
- Weekends as needed

**Education**:

- Bachelor's (preferred)

**Experience**:

- microbiology lab: 4 years (preferred)
- Cleanroom: 3 years (preferred)
- cGMP documentation and record maintenance: 3 years (preferred)
- LIMS: 3 years (preferred)

Ability to Commute:

- Worcester, MA 01601 (required)

Work Location: In person