QC Sample Management Associate

job summary: The candidate in this role will perform cGMP QC Sample Management activities for QC Chemistry, Microbiology, Bioassay, and various Development labs. This position is responsible for the compliant handling, tracking, distribution, and shipment of a wide range of sample types. The individual in this position will ensure samples are managed in accordance with cGMP standards and will collaborate cross-functionally to support timely testing and regulatory readiness.

location:

Norwood, Massachusetts job type: Contract salary: $25 - 30 per hour work hours: 9 to 5 education: Bachelors responsibilities: Sample coordination including cross functional collaboration with internal and external labsReceipt, processing, distribution and shipment of samplesPerform sample aliquoting in a BSC using aseptic techniqueCoordinating domestic and international sample shipmentsCommunication with external QC for samples to be shipped to an external test laboratory.

Receive, maintain, and inspect retention samplesLIMS (LabVantage) sample logging and updateAQL visual inspection of drug productStability program supportSupport controlled temperature unit (CTU) management, maintenance, troubleshooting and alarm response.

Managing/stocking of QC lab suppliesFollow 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 (GDP) 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 cadenceMaintain a safe laboratory working environment qualifications: Qualifications BS in a relevant scientific discipline, preferredA minimum of zero to one years, Quality Control experience in a cGMP organization #LI-KH1 skills: Laboratory Information Management Systems (LIMS), Aseptic Technique, SOP Development, Good Manufacturing Practices (GMP), Quality Control (QC)

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 HRsupport@randstadusa.com. 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. job detailssummary$25 - $30 per hourcontractbachelor degreecategorylife, physical, and social science occupationsreference53550job details job summary: The candidate in this role will perform cGMP QC Sample Management activities for QC Chemistry, Microbiology, Bioassay, and various Development labs. This position is responsible for the compliant handling, tracking, distribution, and shipment of a wide range of sample types. The individual in this position will ensure samples are managed in accordance with cGMP standards and will collaborate cross-functionally to support timely testing and regulatory readiness.

location:

Norwood, Massachusetts job type: Contract salary: $25 - 30 per hour work hours: 9 to 5 education: Bachelors responsibilities: Sample coordination including cross functional collaboration with internal and external labsReceipt, processing, distribution and shipment of samplesPerform sample aliquoting in a BSC using aseptic techniqueCoordinating domestic and international sample shipmentsCommunication with external QC for samples to be shipped to an external test laboratory.

Receive, maintain, and inspect retention samplesLIMS (LabVantage) sample logging and updateAQL visual inspection of drug productStability program supportSupport controlled temperature unit (CTU) management, maintenance, troubleshooting and alarm response.

Managing/stocking of QC lab suppliesFollow 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 (GDP) 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 cadenceMaintain a safe laboratory working environment qualifications: Qualifications BS in a relevant scientific discipline, preferredA minimum of zero to one years, Quality Control experience in a cGMP organization #LI-KH1 skills: Laboratory Information Management Systems (LIMS), Aseptic Technique, SOP Development, Good Manufacturing Practices (GMP), Quality Control (QC)

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 HRsupport@randstadusa.com. 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.