This position is responsible for providing reliable and expedient results from the testing and analysis of incoming materials, intermediates, finished products, swab samples, and other samples to support the commercial and development activities in compliance with all regulatory requirements, company policies and procedures in compliance with cGMP and SOPs.
• Responsible for analysis of incoming materials, intermediates, finished products, swab samples, water samples, environmental monitoring samples, and other samples as needed.
• Responsible for preparing, maintaining, and reviewing data.
• Responsible for assisting senior personnel in investigations and root cause analysis for microbiology related deviations. Assisting senior personnel with laboratory investigations into Out of Specification/Out of Trend results or other laboratory events.
• Responsible for assisting senior personnel with revisions to documentation (including the use of Change Control) such as Standard Operating Procedures, Test Methods, and Specifications.
• Responsible for assisting senior personnel with method suitability for compendial methods.
• Responsible for assisting senior personnel in the execution of complex projects such as method transfers, validations, and regulatory reports.
• Responsible for assisting senior personnel in projects of an advanced scope and complexity as assigned.
• Responsible for assisting senior personnel with communications with multiple departments including manufacturing, planning, and regulatory affairs.
• Responsible for completing all training requirements and maintaining 100% compliance with all assignments.
• Responsible for maintaining work areas and performing job functions in a safe and efficient manner in accordance with company policies and procedures, Good Manufacturing Practices (cGMP’s), Standard Operating Procedures (SOP’s) and Batch Record instructions.
• Responsible for performing additional related duties as assigned.
Any equivalent combination of education, training and/or experience that fulfills the requirements of the position will be considered.
Education/Certification/Experience:
• Requires a Bachelor’s degree, preferably in Microbiology or Biology, or equivalent education/experience.
• Prefer one to two years of relevant experience in a regulated laboratory environment.
• Prefer working knowledge of cGMP, DEA, and other applicable industry regulatory requirements as they relate to the production of pharmaceutical products and associated quality systems.
• Prefer experience with nonsterile pharmaceutical microbiology testing: Microbial Limits Testing (MLT)
• Prefer experience with water testing and environmental monitoring
Skills/Knowledge/Abilities:
• General understanding of the principles of microbiology as it applies to sterilization, bioburden testing, media preparation and qualification, aseptic technique, general traditional microbiology laboratory techniques.
• Experience with Gram staining and basic microscopy
• Computer proficiency with comprehensive working knowledge of MS Office products
• Ability to manage priorities and reporting requirements.
• Ability to perform routine tasks without direct supervision and perform non-routine tasks with some oversight
• Ability to communicate effectively with excellent written and oral communication skills.
• Ability to interact positively and collaborate with co-workers, management and other internal stakeholders.
• Self-directed with ability to organize and prioritize work.
• Detail oriented with ability to analyze information, create metrics and articulate the link to business needs/objectives.
Problem Solving:
• Proactively works on problems of a moderate scope where evaluation of contributing factors requires the analysis of situations or data and knowledge of various known and unknown factors.
• Seeks out all resources when selecting methods and techniques for obtaining results.
• Acts independently and proactively to recommend and administer methods and procedures for problem resolution.
TRAVEL REQUIREMENTS
N/A
We offer a competitive benefits package, including:
Comprehensive Health Insurance: Medical, Dental, Vision, and Prescription coverage starting on the first day of employment, providing the employee enrolls.
Time Off: Paid Time Off including vacation, sick/safe time, caretaker time and holidays.
The total compensation may also include restricted stock units and discretionary awards, depending on the position offered. Details of participation in these benefit plans will be provided if an employee receives an offer of employment.
The internal career site is available from your home network as well. If you have trouble accessing your EC account, please contact your local HR/IT partner.
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