MCS Associate Quality Control

Payrate: $25.00- $26.00/hr.


Summary
Under minimal supervision, analyze environmental monitoring samples, cross check sample requirements against SOPs and enter results in a laboratory information management system (LIMS) and/ or SmartLab (LMES). This position will work in a team environment, collaborating within the lab as well as with various colleagues in the network.


Responsibilities:

• At all times, align with safety guidelines from EHSS, cGMPs, and other applicable regulatory requirements.
• Adhere to good documentation practices.
• Complete all required training before starting any tasks.
• Work with Laboratory Information Management System (LIMS) and/ or SmartLab (LMES) with efficiency and accuracy.
• Ability to manage and coordinate all tasks assigned and effectively complete all expected deliverables in a timely manner.
• Ensure equipment preventive maintenance is performed by requirements and by due date as assigned.
• Participate in the investigation of out-of-specification and/ or non-conforming test results.
• Supports internal and external inspections and audits as needed (lab preparation, data retrieval etc.).
• Troubleshoot, solve problems, and communicate with relevant team members.
• Implement prevention or corrective actions based on lab manager feedback.
• Perform QC Support tasks e.g., organization and cleaning of the lab, checking to ensure removal of expired media performed, archiving documentation, preliminary plate readings etc.
• Support Microbiology lab with analytical testing.
• Implementation of lab improvements to ensure an efficient and productive lab environment.

Basic Qualifications:

• Bachelor's degree in relevant scientific discipline or other appropriate specialties such as Life Sciences and one-year related experience or an equivalent combination of education and relevant work experience.
• Physical Requirements:
• Frequently sit, grasp lightly, use fine hand manipulation, repetitive handling of agar plates, perform desk-based computer tasks, and lift, carry, push, and pull objects up to 15 pounds.

Preferred Qualifications:

• GxP experience, specifically practices and requirements in the testing of biopharmaceuticals.
• Experience using various QC systems such as CDOCS (Veeva Vault), LIMS and/or SmartLab (LMES).
• Experience and knowledge of Data Integrity Requirements in QC systems.
• Proficient in Microsoft Office (i.e., Outlook, Word, Excel, PowerPoint).
• Excellent problem-solving capabilities and attention to detail in delivering right first-time results.
• Experience of collaboration within and across functional areas.
• Excellent written, verbal communication, organizational skills, and attention to details.

Must Have Skills:

• Analytical & Instrumentation Proficiency
• Regulatory & Compliance Expertise (GxP)
• Data Integrity & Documentation Discipline

Pay Transparency: The typical base pay for this role across the U.S. is: $25.00- $26.00/hour . Non-exempt positions are eligible for overtime at a rate of 1.5 times the base hourly rate for all hours worked in excess of 40 in a work week, or as required by state or local law. Final offer amounts, within the base pay set forth above, are determined by factors including your relevant skills, education and experience. Full-time employees are eligible to select from different benefits packages. Packages may include medical, denmatch, lifeion benefits, health savings accounts with qualified medical plan enrollment, 10 paid days off, 3 days paid bereavement leave, 401(k) plan participation with employer match, life and disability insurance, commuter benefits, dependent care flexible spending account, accident insurance, critical illness insurance, hospital indemnity insurance, accommodations and reimbursement for work travel, and discretionary performance or recognition bonus. Sick leave and mobile phone reimbursement provided based on state or local law.


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