Quality Analyst Micro
3-6 Months
Billerica, MA
Max PR: $30.00
Perform testing on incoming materials, finished products and stability studies in QC Laboratory.
Job Responsibilities
- Perform routine QC testing in accordance with SOPs and cGMP guidelines. Some supervision required.
- Perform verification of data to ensure accuracy. Perform approval upon discretion of supervisor.
- Assist with audit readiness of laboratory area and calibration and maintenance of laboratory equipment.
- Utilize a range of electronic systems such as LIMS and document/equipment management software.
- Author SOP changes; participate in change controls, CAPAs, other quality systems.
- Resolve routine problems by utilizing appropriate resources. Assist in investigations.
- May assist on special projects as needed. Help with continuous improvement.
- Train on and maintain knowledge of current regulatory requirements and relevant internal procedures.
- Team player who can work independently with quality and attention to detail. Good communication skills both oral and written, professional conduct. Effectively and efficiently participate in assigned tasks in a quality manner.
- Actively promote safety rules and awareness. Reports and takes initiative to correct safety & environmental hazards. Work with potentially hazardous chemical, radiological and/or biological materials on a daily basis. Demonstrate good safety practices at all times including the appropriate use of protective equipment.
- *In case of absence the “Reports to” Manager above or a peer incumbent will function as a backup for this position.
Education & Qualifications
- Typically requires 1-3 years of previous experience in the pharmaceutical industry, related GMP environment, or equivalent. Previous experience preferred.
- Requires a BA/BS degree in a related scientific discipline (e.g. chemistry, biology) or equivalent combination of education and experience.
- Familiar with aseptic technique
- Perform routine Environmental Monitoring and utilities testing
- Perform sterility, microbial limits and Endotoxin testing, identify and trend microorganisms
- Some non-routine travel may be required.
- Flexibility with scheduling requirements-may include shifts, overtime, weekends and holiday coverage, including during adverse weather conditions.
- Must be able to lift 50 lbs.