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Analyst II, Quality Control Microbiology

Employer
Resilience
Location
West Chester, OH
Start date
Nov 18, 2023

View more

Discipline
Quality, Quality Control, Science/R&D, Microbiology
Required Education
Bachelors Degree
Position Type
Full time
Hotbed
Best Places to Work

Job Details

A career at Resilience is more than just a job – it’s an opportunity to change the future.

Resilience is a technology-focused biomanufacturing company that’s changing the way medicine is made. We’re building a sustainable network of high-tech, end-to-end manufacturing solutions to better withstand disruptive events, serve scientific discovery, and reach those in need.

For more information, please visit www.resilience.com

Position Responsibilities:

  • Prepare documentation of activities, actions, and/or results.

  • Read SOPs (Standard Operating Procedures) and excerpts from technical documentation.

  • Train others on systems, software, equipment, machines, procedures, and/or processes.

  • Establish visual tracking and other tools to enhance Audit readiness and trend analysis.

  • Lead and coordinate investigations and studies with little supervision.

  • Analyze trends in data to provide accurate descriptions, identify root causes, and/or identify solutions or improvements.

  • Investigate and Close out deviations, CAPAs, and/or AFCAs as needed.

  • Monitor records to ensure compliance with regulatory requirements.

  • Alert others (for example: supervisor, manager) when problems occur outside of SOPs (Standard Operating Procedures).

  • Collect, record, and report metrics.

  • Monitor equipment and/or systems for performance and problem indicators.

  • Consult cross-functionally as an SME (Subject Matter Expert) on systems and/or processes within a functional area.

  • Ensure that others carry out laboratory duties in a manner consistent with cGMP.

  • Ensure that outgoing product is reviewed, documented, and releasable.

  • Maintain accurate and complete records (for example: laboratory notebooks, quality records, sample receipts).

  • Perform logbook reviews.

  • Review and approve quality documentation.

  • Serve as SME (subject matter expert) for lab operations.

  • Interact with regulatory agency personnel during audits and inspections.

  • Perform regular audits of SOPs (Standard Operating Procedures) and/or work instructions.

  • Review and approve documentation needed for qualification of equipment and processes.

  • Write, review, and revise SOPs (Standard Operating Procedures)

  • Author, review, and revise documentation needed for cGMP (Good Manufacturing Practices) manufacturing of commercial product.

  • Interact with other departments to implement corrective/preventative actions.

  • Review and approve OCMs, change controls, and document revisions.

  • Provide "off shift" support (for example: night shift support if you normally work day shift).

  • Assess and implement improvements in productivity, waste generation, quality and cost.

  • Lead change control activities.

  • Lead teams in root cause analysis sessions.

  • Perform routine utility sampling and testing activities.

  • Provide 24/7 "on-call" support to others.

  • Recommend compliance resolutions to management.

Minimum Qualifications:

  • Experience in a regulated or cGMP environment.

  • Experience supporting microbiological testing in a pharmaceutical operation environment.

  • Proficiency in solving complex problems and conducting root causes investigations.

  • Strong technical writing skills, proficiency with MS Word and Office


Preferred Qualifications:

  • Bachelor’s degree in Biology, Microbiology or related discipline

  • Proficiency with laboratory instrumentation

  • Working knowledge of cGXP requirements and a strong familiarity with sterile pharmaceutical production operations.


This position may also include the following conditions:

1. Physical work - This role primarily active, including infrequent lifting, frequent standing, walking, bending, stooping, reaching, repetitive motion, noise exposure, visual and auditory acuity, and wearing personal protective equipment are required.

2. Quality Statement: All employees are expected to adhere to the Quality Management System established in the Quality Manual, Quality Policy, Standard Operating Procedures, Current Good Manufacturing Practices, and any other applicable regulations and standards to the duties within their role.



The items described here are representative of those that must be met successfully to perform the essential functions of this job.

Resilience is an Equal Employment Opportunity Employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender perception or identity, national origin, age, marital status, protected veteran status, disability status, physical or mental disability, genetic information, or characteristic, or other non-job-related characteristics or other prohibited grounds specified in applicable federal, state, and local laws. Requests for reasonable accommodation can be made at any stage of the recruitment process.

Resilience offers employees a robust total rewards program including equity, an annual cash bonus program, a 401(k) plan with a generous company match and our benefits package which is thoughtfully designed to support our employees with great healthcare (including medical, dental and vision), family building benefits, life and disability insurance, flexible time off, paid holidays, other paid leaves of absence, tuition reimbursement and support for caregiving needs. Our target annualized base pay hiring range for this position is $60,000.00 - $82,500.00. 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. Excited about Resilience and the biomanufacturing revolution? We encourage you to apply and start a conversation with one of our recruiters.

Company

Resilience is a technology-focused biomanufacturing company dedicated to broadening access to complex medicines. Founded in 2020, the company is building a sustainable network of high-tech, end-to-end manufacturing solutions to ensure the treatments of today and tomorrow can be made quickly, safely, and at scale. Resilience seeks to free its partners to focus on the discoveries that improve patients’ lives by continuously advancing the science of biopharmaceutical manufacturing and development. For more information, visit www.Resilience.com and follow us on Twitter @IncResilience 

Company info
Website
Location
9310 Athena Circles
La Jolla
CA
92037
United States

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