Technician - Production/Service - Marietta, PA, United States - The Accuro Group

Description

Business Title:
| QC Technician


Location:
Marietta, PA 17547


Job Type:
Contract (12 M)

Note:
Position may require employees to work in a rotational schedule. This schedule may include holidays, and weekends; over-time may be required.


Job Purpose:
Collect environmental monitoring and utility samples. Collect PEMS data. 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 glass-ware cleaning and stocking, level one audits, 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.


Job 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.


Skills & Experience Required:
Associate degree or higher in relevant field

1+ year of GxP experience

Knowledge of standard laboratory technique

Proficiency in MS Word and Excel


Preferred experience:
Some experience in analytical systems including quality control, validation, documentation, and compliance.

Able to interact with peers, subordinates and senior personnel in multidisciplinary environment including engineering, facility operations, validation, production, and QA.

Demonstrated familiarity with cGMP's, facility regulatory guidelines and standard operating procedures.