Assistant Director of Quality Control (Microbiology)

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Job description

Assistant Director of Quality Control (Microbiology) Position: Position Summary:

Site Head of Quality Microbiology organization, provides leadership to Microbiology QC, QC in process control and Stability groups responsible for providing QC technical expertise, oversight, and testing to support new product development, regulatory submissions, sustaining projects, and release of commercial products. Manages staff of approximately 50 Micro Associates. Site Subject Matter Expert on Microbiology and physical testing, method and process validation, and regulatory compliance requirements for pharmaceutical manufacturing. Provide QC technical and tactical support for the company manufacturing facilities to ensure compliance with cGMP and regulatory requirements both internally and externally. Plan, organize and manage the activities to ensure timely completion of group's tasks. Interact with FDA and other regulatory authorities as Subject Matter Expert for Irvine Quality Microbiology processes, procedures and analytical methods. Manage the development and implementation of related programs to maximize efficiencies of staff, testing and budgetary resources necessary to support the company goals while complying with regulatory requirements.

Responsibilities: Essential Duties

Manages the quality control activities of an organization.
Assists with overseeing tasks associated with inspecting and testing products.
Ensures that products or services meet quality standards and develops corrective action when needed.
Develops, implements and assesses processes and policies designed to test products and services.
Monitors and evaluates current testing processes, making recommendations for improvements when necessary.
Enforces regulatory compliance.
Conducts visual and physical inspections of company products and materials.
Monitors the performance of the quality control staff, ensuring that the quality control department meets organizational objectives.

The job function listed is not exhaustive and shall also include any responsibilities as assigned by the Supervisor from time to time.

General:
It shall be the duty of every employee while at work to take reasonable care for safety and health of himself/herself and other persons.

Expertise: Knowledge & Skills

Requires breadth of professional field and industry knowledge.
Ability to integrate critical information and champion advanced strategies/concepts through the organization.
Drives development of advanced technologies, principles and processes.
Manages entry to intermediate level employees of a department or a function with 1 or 2 sections.
Ensures budgets, schedules, and performance requirements are met.
Judgement is required in resolving complex problems based on experience.
Contacts are primarily with department supervisors, leads, subordinates, and peers.
Occasional contact with external contractors/vendors.

Qualifications

Expertise: Qualifications -Education/Experience/Training/Etc

Required:

Bachelor's degree required, Master's degree preferred.
10-12 years related experience required.
Applicable industry/professional certification preferred.
Regular and predictable attendance
Occasional business travel required, Valid driver's license and passport
There's a 15% Sign-On Bonus and Relocation Assistance is also available!!

Nesco Resource and affiliates (Lehigh G.I.T Inc, and Callos Resource, LLC) is an equal employment opportunity employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, disability, age, or veteran status, or any other legally protected characteristics with respect to employment opportunities.