QC Lab Tech

Proclinical is currently recruiting for a QC Lab Tech with a global pharmaceutical company located in Marietta, PA. Successful candidate will participate in utility sampling rotation on average two days per week, monitor AMS alarms, perform routine Equipment PM tasks, preparing items for autoclaving.

Job Responsibilities:

• Perform QC testing as scheduled by QC Planner. Tests include: data review, utility testing, EM Plate incubation/reads, utility and EM sampling
• Participate in utility sampling rotation (average 2-3 days/week.) Perform routine lab tasks, including: monitor AMS alarms, perform safety shower/eyewash flushes, perform equipment PMS, wrap materials for autoclave, wash glassware, and stock supplies.
• Complete testing to satisfy established timelines and all applicable regulations.
• Document raw data and results using Good Documentation Practices.
• 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 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. Identify ZAPs and HAZIDs. Follow the EHS guidelines established on site.

Skills and Requirements:

• Prefer 2+ years' GMP laboratory testing experience (raw materials, microbiology testing, plate reading), or AS or BS in biology, microbiology, chemistry or related field with 1+ years' GxP experience.
• Required to demonstrate Good Documentation practices, and the ability to execute procedures as written.
• Responsible for recording results and comparing to specifications.
• Knowledge of standard laboratory technique.
• Ability to demonstrate good aseptic practices.
• 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. Able to work with limited supervision.
• 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.
• 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 interact with people from various domains (Regulatory, QA, other analytical groups inside the Company.)
• Demonstrated familiarity with cGMP's, facility regulatory guidelines and standard operating procedures.

To Apply:

Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.

In case you have difficulty in applying or if you have any questions, please call Sarah Beshara at (+1) 267-477-3355 or upload your resume on our website - www.proclinical.com.

A full job description is available on request.

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

Proclinical Staffing is an equal opportunity employer.

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