Senior Quality Control Analyst I (Micro) PC 1494

Miltenyi Biotec • Gaithersburg, MD

4d • $43 - $51 • Onsite

About The Position

Your Role: This position is primarily responsible for executing day-to-day activities under minimal supervision to support the microbiology programs (lentiviral vector and cell and gene therapy) in all stages of development in compliance with internal company policies and regulatory guidance (ICH, CFR, etc.). To be considered for this position, candidates must meet the minimum education, experience and skills listed in the applicable section. Essential Duties and Responsibilities: Receive and track sample submissions from multiple departments. Perform microbiological testing activities (e.g. bioburden, endotoxin, sterility, special studies, method qualifications). Conduct and write investigations independently or with minimal assistance. Display sound scientific/technical judgment and ability to review work for overall adequacy and accuracy. Contribute actively to work on and resolve various scientific/technical problems of moderate scope and complexity. Work with minimal supervision. Follow established written procedures and processes. Support improving existing procedures and/or establishing new procedures. Identify out of trend or atypical results and supports ongoing investigations; Initiate quality event investigations for deviations, OOT, and OOS events. Interact with functional peer groups; provide microbiological data to other departments upon request. Support and assist with documenting microbiological program metrics in support of management review. Maintain trackers for microbial data. Initiate contract laboratory purchase orders for microbial testing; coordinate sample shipments to contract laboratories and/or sample storage vendors. Coordinate Lab equipment maintenance.

Requirements

• Bachelor’s (B.S.) or Master’s (M.S.) degree in biotechnology, biology, chemistry or similar field from a four-year college or university
• At least 5 years prior experience in a cGMP microbiology laboratory in Quality control, and experience working with microorganism cultures.
• Strong knowledge of aseptic technique and product sample handling.
• Strong organizational skills and attention to detail are required.
• Excellent written and oral communication skills and must be able to interact with a cross-functional team member.
• Strong skills with Microsoft Office applications (Excel, Office, PowerPoint, Outlook, etc.).

Responsibilities

• Receive and track sample submissions from multiple departments.
• Perform microbiological testing activities (e.g. bioburden, endotoxin, sterility, special studies, method qualifications).
• Conduct and write investigations independently or with minimal assistance.
• Display sound scientific/technical judgment and ability to review work for overall adequacy and accuracy.
• Contribute actively to work on and resolve various scientific/technical problems of moderate scope and complexity.
• Work with minimal supervision.
• Follow established written procedures and processes.
• Support improving existing procedures and/or establishing new procedures.
• Identify out of trend or atypical results and supports ongoing investigations; Initiate quality event investigations for deviations, OOT, and OOS events.
• Interact with functional peer groups; provide microbiological data to other departments upon request.
• Support and assist with documenting microbiological program metrics in support of management review.
• Maintain trackers for microbial data.
• Initiate contract laboratory purchase orders for microbial testing; coordinate sample shipments to contract laboratories and/or sample storage vendors.
• Coordinate Lab equipment maintenance.

Benefits

• In addition to your salary, the Company offers a comprehensive benefits package, including health, vision, and dental insurance, as well as a 401(k) plan.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 501-1,000 employees