QC Microbiology Technical Manager in West Columbia, South Carolina at Nephron Pharmaceuticals

QC Microbiology Technical Manager provides oversight of the day-to-day technical operations of Microbiology department, including but not limited to capacity planning, protocol development, process changes, data evaluation, and resource management in a high-growth, fast-paced, dynamic work environment while ensuring compliance with FDA regulations. Leads microbiology projects and process improvements, including Microbiology Protocols, Media Fill receipt and evaluations, investigations, personnel training, Compliance and Regulatory items, and any other special projects as required.

Essential Duties and Responsibilities:

• Provides technical leadership for the Microbiology team to ensure regulatory requirements are met.
• Leads capacity planning initiatives for Microbiology; this includes developing and/or reviewing new equipment resourcing, writing and reviewing new processes for onboarding new cleanroom suites, equipment, Microbiology Protocols, and other laboratory processes and initiatives.
• Develops and/or reviews documentation related to new process development such as protocols, SOPs, and Quality Improvement Plans, as applicable.
• Works with shift leadership to ensure Microbiology laboratory supply and material inventory is maintained appropriately within the lab and cleanrooms as required. The management of inventory in regards to various studies and protocols is essential.
• Reviews and drafts procedures as necessary; supports training initiatives for staff in regards to new processes, procedures, or equipment.
• Works with Microbiology Project Manager(s) to ensure coordinated initiatives are assigned and communicated between all Microbiology personnel. Ensure all project deadlines are met, as needed.
• Participates as an SME in regulatory inspections, as well as inspection readiness activities.
• Identifies resources needed for dynamic, ongoing projects throughout the Microbiology department; bridges the gap between Microbiology and other departments in terms of communication and coverage for special projects, protocols, and other initiatives.
• Assists in fostering/establishing a constructive learning environment and relationship with incoming Microbiology laboratory personnel; encourages all staff to seek and maximize learning opportunities through the department.
• Communicates Microbiology-related observations, issues, problems, discrepancies, and any violations of company policies or procedures to Director of Microbiology or designee.

Supplemental Functions:

• Performs other duties as assigned.

Knowledge & Skills:

• Experienced in general computer operation (including Microsoft Office) and navigation of environmental monitoring sample databases (i.e. MODA, LabVantage).
• Thorough knowledge of cGMP and regulatory , including but not limited to: FDA Guidance for Industry, Code of Federal Regulations, USP, Annex 1, and ISO, as applicable.
• Knowledgeable of cleanroom design and classifications (ISO 14644). Must also be proficient in the operation of non-viable particulate counters, viable air samplers, and aseptic techniques/gowning.
• Great communication, documentation, problem solving, and time management skills; must be able to multitask.
• Communicates effectively and consistently with all levels of staff.
• Flexible and open to receiving and providing training in other departmental areas.
• Must have strong organizational skills, attention to detail, and ability to manage multiple projects or assignments at one time; must also possess the initiative and follow through to implement, track, and achieve on-time completion of projects as assigned.
• Specific expertise, skills, and knowledge within microbiology gained through education and experience.
• The ability and willingness to change direction and focus to meet shifting organizational and business demands.
• The ability to create and contribute to a work environment that values people, encourages trust, teamwork, and open communication, and provides participation, learning, feedback and recognition.
• The ability to effectively manage one self, demonstrates integrity, be productive under pressure, and achieve development goals.
• The ability to take strategic objectives and accept accountability to drive results through effective actions.
• Position encounters the following environmental factors: heat, water, hazardous materials including biohazardous waste, laboratory chemicals and other non-specified hazardous materials that are project specific.
• Incumbents are required to wear safety glasses, hearing protection, PPE Gowning, and other non-specified protective equipment as necessary.

Education/Experience:

• Bachelor’s Degree or related industry experience preferred.
• Minimum of 3 years experience in a cGMP-related environment.

Working Conditions / Physical Requirements:

• This position requires bending, typing, lifting (up to 40 1bs.), reaching, vision, hearing, standing, sitting and walking throughout the facility.
• Hours of work: 8-hour shift Monday thru Friday, or as needed based on company demand.