Associate II, Quality Control, Chemistry Data

job summary:
The individual in this role will perform cGMP QC Chemistry testing for QC Chemistry, release, stability and in process samples. This role may support special projects as needed.

location: Norwood, Massachusetts
job type: Contract
salary: $30 - 35 per hour
work hours: 3 to 11
education: Bachelors


responsibilities:

• Performs routine analytical chemistry testing including HPLC, UPLC, UV, Particle Analysis and Dynamic Light Scattering, etc.
• Supports special projects as assigned.
• May assist with Troubleshoots assay methods and equipment.
• Performs data entry and supports trending.
• Performs general laboratory support activities including reagent preparation, sample management, equipment maintenance, lab housekeeping etc.
• Supports authoring of SOPs, protocols and reports.
• LIMS (LabVantage) sample result entry, execution of Electronic Assay Forms in LIMS
• Perform HPLC and NaOH plate reader based assays in support of manufacturing process stat testing as needed
• Stability program support
• Managing/stocking of QC lab supplies
• Write/revise SOPs, protocols and reports.
• Complete and maintain cGMP documentation for work performed.
• Participate in authoring quality systems records such as deviations, change controls, CAPAs
• Establish and maintain a safe laboratory working environment.
• Follow all relevant GxP regulations, guidelines, and company policies to ensure compliance with regulatory and internal requirements.
• Execute tasks precisely as defined in internal guiding documents including but not limited to standard operating procedures (SOPs) and work instructions.
• Follow Good Documentation Practices and Data Integrity requirements to ensure data, documentation, and records are completed and maintained for use by the business and available to support audits or inspections.
• Complete training in assigned required learning plan according to the defined timing and the prescribed requalification cadence.

qualifications:

Qualifications

• Education: BA/BS in relevant scientific discipline
• Experience: 2 years of Laboratory experience.
• Demonstrated aptitude or ability to learn in order to gain a strong understanding of GxP regulations.

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skills: Quality control, HPLC, SOP, Chemistry, GMP (Good Manufacturing Practice)


Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.

At Randstad, we welcome people of all abilities and want to ensure that our hiring and interview process meets the needs of all applicants. If you require a reasonable accommodation to make your application or interview experience a great one, please contact [email protected].


Pay offered to a successful candidate will be based on several factors including the candidate's education, work experience, work location, specific job duties, certifications, etc. In addition, Randstad offers a comprehensive benefits package, including: medical, prescription, dental, vision, AD&D, and life insurance offerings, short-term disability, and a 401K plan (all benefits are based on eligibility).


This posting is open for thirty (30) days.

It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.