Quality Control Laboratory Technician

Job Title: QC Lab Technician - Level 1 US

Duration: 1 Year (Possibility of extension)

Location: Marietta, PA

Max PR: $26.40/ hr

Shift: Standard Day Shift (Mon-Fri; 40 hrs/wk; 8 hrs/day) start time flexible between 7:30am and 8:30am; 100% onsite

DESCRIPTION:

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.

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.

EDUCATION/REQUIREMENTS:

Knowledge/ Education/Previous Experience Required*

• High School degree; Assoc. or B.S. in a scientific discipline preferred

Job-Related Experience:

• Prefer minimum of two years GMP laboratory testing experience (raw materials, wet chemistry, compendial testing, packaging components), or Assoc. or B.S. in biology, microbiology, chemistry or related field with minimum of one year GxP experience.

Other Job-Related Skills/Background

• 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.

• Must be well organized, flexible, open-minded and dynamic.

• Must have demonstrated self-direct work habits and strong communication skills.

• Must be a 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.

Preferred:

• Some experience in analytical systems including quality control, validation, documentation and compliance preferred.

• Strong interpersonal skills. Solid team player able to function within team based organization.

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

• Able to prioritize and decide appropriate course of actions.

• Ability to understand client’s needs (producers) and to interact with people from various domains (Regulatory, QA, other analytical groups inside the Company.)

• Demonstrated ability to perform all job duties with limited supervision.

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