QC Lab Technician

4 weeks ago


Marietta, United States Randstad Life Sciences Full time
Job DescriptionJob Description

Immediate opportunity for a QC Lab Technician to support testing and sampling, including environmental monitoring, and product testing for a leading, global biopharmaceutical company in Marietta, PA. 

Schedule Shift: 1st shift, Mon.-Fri., 7:30/8:30am - 4:00/5:00pm

Position Type: Long term, contract role for 1 year (through 5/5/2025) with possibility of extension

As a QC Lab Technician you will collect environmental monitoring and utility samples. Collect PEMS data.  Perform wet chemistry testing such as TOC, conductivity, nitrates, and raw material identification. Perform retain inspections. Perform component testing for packaging and process materials such as cartons, syringes, glass vials, tubing, etc. Perform routine laboratory tasks such as safety shower and eye-wash testing, glass-ware cleaning and stocking, level one audits, daily pH meter and balance calibration, etc. Perform tasks associated with ordering laboratory supplies and maintaining laboratory equipment. Follow and work in accordance with company policies, SOPs and cGMP standards to ensure compliance with all applicable regulations. Identify atypical events or potential problems and communicate these situations with appropriate personnel.

Essential Duties and Responsibilities:

  • Perform Environmental Monitoring duties related to viable air, viable surfaces, swabs, and non-viable air sample collection as well as performing utility sampling. Perform associated sample reads/testing.
  • Generate all paperwork and labels associated with sampling to meet SOP requirements. Collect PEMS data.
  • Responsible for assisting senior staff with the harmonization of compendial methods with other vaccine sites. This will include the review of documents, identification of potential gaps and revision of those documents. Handle special projects such as abnormal test results, investigations and validation studies as needed. Identify data trends and escalate as needed.
  • Responsible for maintaining and ordering sufficient reagents and supplies, ordering equipment and maintaining the equipment in good working conditions in a calibrated and validated status. Performing routine laboratory tasks such as safety shower/eyewash checks, autoclaving materials, performing glass-wash and stocking supplies, daily pH meter and balance calibration, etc. Ensure labs are in a ‘GMP, safe, analytical-testing readiness’ state.
  • Assure that all required documentation including records and logs, is complete and accurate according to the current GMPs. File and archive laboratory records and data in accordance with GMPs and SOPs.
  • Revise and write change controls, SOP’s, and other GMP documents as required.
  • When assigned to rotating shift work; work independently and without direct supervision to perform normal operating routines and emergency response procedures.
  • Communicate and report status of operations as well as variances to supervisors. Take appropriate actions and escalate issues immediately.
  • Perform all tasks with a safety mindset. Following the EHS guidelines established on site.

Qualifications:

  • High School required.  Associate's degree (AA/AS) or Bachelor's degree (BS) preferred.
  • One (1) to two (2) years GMP laboratory testing experience (raw materials, wet chemistry, compendial testing, packaging components).
  • Knowledge of standard laboratory technique.
  • Computer skills required in Excel and Word.
  • Ability to follow written procedures and document results in a neat and precise manner.
  • Well organized, flexible, open-minded and dynamic.
  • Demonstrated self-direct work habits and strong communication skills.
  • Committed team player prepared to work in and embrace a team based culture.
  • Ability to work within a multi-skilled team.
  • Maintain attention to detail, while completing multiple or repetitive tasks.
  • Demonstrate a serious commitment to accuracy and quality while meeting goals or deadlines.
  • Maintain a high level of integrity while balancing multiple priorities and responsibilities.
  • Position may require employees to work in a rotational schedule. This schedule may include holidays, and weekends; over-time may be required.
Company DescriptionOne of the best known companies in the industryCompany DescriptionOne of the best known companies in the industry

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