Analyst II, QC Microbiology

About the role

The Analyst II, QC Microbiology role supports the Microbiology Department by performing quality-related tasks for pharmaceutical products to include documenting and conducting testing on a variety of samples, such as raw materials, in-process and finished products, stability samples, water, gas, and environmental samples.

Job Responsibilities

• Read SOPs (Standard Operating Procedures) and excerpts from technical documentation.
• Write, review, and revise SOPs (Standard Operating Procedures) and/or work instructions for cGMP (Good Manufacturing Practices) manufacturing of commercial product.
• Complete required training and may train others.
• Conduct troubleshooting activities.
• Gather, organize, and communicate operational information to others.
• Facilitate team meetings to discuss progress, initiatives, and/or other matters.
• Participate in investigations involving manufacturing process areas, related to QC processes or data, such as sampling, deviations potentially affecting QC results, investigational sampling, and testing.
• Auxiliary activities include assisting with coordinating activities of support groups, identifying trends in data, providing accurate descriptions, identifying root causes, and/or identifying solutions or improvements, demonstrating proficiency on authoring Quality records (Deviations, CAPAs, and Change Controls), identifying temporary and permanent fixes to address issues, alerting supervisor or manager when problems occur outside of SOPs (Standard Operating Procedures), collecting, recording, and reporting metrics, monitoring equipment and/or systems for performance and problem indicators, wearing gowning, sterile garments, and PPE (Personal Protective Equipment) as required by specific activities, consulting cross-functionally as an SME (Subject Matter Expert) on systems and/or processes within a functional area, performing logbook reviews, leading or participating in process improvement activities and teams to meet strategic goals, using MAXIMO and/or CMMS (Computerized Maintenance Management System) to manage logistics, interacting with regulatory agency individuals during audits and inspections, authoring, reviewing, and revising documentation needed for cGMP (Good Manufacturing Practices) manufacturing of commercial product, attending inter-departmental meetings to discuss matters involving the coordination of multiple departments, coordinating qualification activities, performing routine sampling activities on the facility utilities, recommending compliance resolutions to management.

Minimum Qualifications

• Working knowledge of cGXP requirements and a strong familiarity with production operations.
• Good problem solving skills.

Preferred Qualifications

• Bachelor’s degree in biology, microbiology, or related discipline.
• At least 2 years of laboratory experience in pharmaceutical industry.
• Prior experience supporting microbiological testing in a sterile pharmaceutical operation environment.

Conditions

• This role is primarily non-sedentary. May include but not limited to standing, walking, repetitive motion, and chemical usage.

Benefits

• Annual cash bonus program.
• 401(k) plan with a generous company match.
• Thoughtfully designed benefits package including:
  • Healthcare (medical, dental, and vision).
  • Family building benefits.
  • Life and disability insurance.
  • Paid vacation, paid holidays, other paid leaves of absence.
  • Tuition reimbursement.
  • Support for caregiving needs.

Pay

The target base pay hiring range for this position is $60,000.00 - $86,250.00 per year. Actual base pay is dependent upon a number of factors, including but not limited to, the candidate’s geographical location, relevant experience, qualifications, skills and knowledge.

Schedule

Not specified.

Skills

Not specified.

Benefits

• Not specified.

Pay

Not specified.

Schedule

Not specified.

Skills

Not specified.