PRIMARY DUTIES AND RESPONISIBITIES
- Leads the development and implementation of process improvement initiatives that promote increased productivity for the QC Micro and Validation groups.
- Coordinates work projects to appropriately prioritize laboratory workload to meet client requirements as related to quality on-time performance and TAT (Turnaround Time).
- Distributes work to staff in order to maximize productivity.
- Maintains quality performance metrics conducts routine metrics review and root cause analysis in collaboration with the microbiologists.
- Devises and develops processes and methods for the solution of technical problems.
- Trains mentors and supervises staff on an as needed basis.
- Confers with Quality Assurance and Microbiology Director to design and/or improve standard operating procedures and/or training programs.
- Responsible for scheduling work in support of maintaining all deadlines.
- Ensures that laboratory supplies consumables standards are available to perform the analyses within the required project turnaround time.
- Communicates project delays quality and or technical issues to the Microbiology Director and/or Client Services/Sales Team as needed.
- Reviews lab nonconformance (investigation and deviations) with microbiologists. Conducts root cause analysis and implements solutions in collaboration with the team.
- Manages all aspects of office and lab operations as related to operating costs.
- Responsible for the interviewing and the hiring of employees.
- Provides regular ongoing performance feedback while serving as a coach and mentor.
- Responsible for developing and communicating goals to microbiologists.
- Ensures all work is performed in compliance with Standard Operating Procedures Good Manufacturing Practices Regulations of the Food and Drug Administration Company Client and Pharmacopeial Methodologies.
- Follows all safety rules and regulations.
- Follows all cGMP rules and regulations.
- Documents work in a clear and organized manner.
- Maintain a clean and orderly laboratory environment.
- Proper handling of hazardous waste in compliance with the Company and hazardous waste rules.
REQUIREMENTS & QUALIFICATIONS
Qualifications include a Masters and/or Bachelors degree in Microbiology or a related discipline is required. Must have laboratory experience with a minimum of 5 years of related work experience. Knowledge of cGMPs and related compliance regulations and guidances required.
Must have experience with the various products and services the Company offers including LIMS and ELN and Microbiology.
This position requires a self-starting motivated person who possesses excellent interpersonal skills; who is able to assume a leadership role in the organization; and who is able to effectively interact with all departments within the company and with client personnel.
MINIMUM SKILLS REQUIREMENT
- Demonstrated skills in laboratory techniques.
- Solid computer skills.
- Knowledge of safe laboratory practices including the proper procedures in handling chemicals and samples.
- Must be a team player with integrity and concern for the quality of Company products services and staff members.