Oversee the QC Microbiologists performing environmental monitoring, water testing and other client-specific microbiology testing in support of aseptic manufacturing operations. Duties include, but are not limited to: oversight of analysts performing complex microbial analysis, review of microbiology test results, assistance with method development and validation work, oversight of contract laboratories performing microbiological analysis on behalf of GRAM, monitoring facility / personnel performance with regards to contamination control, and investigation of out of trend / out of specification results.
ESSENTIAL DUTIES & RESPONSIBILITIES
- Provide leadership to Quality Specialists of various levels. Responsibilities include hiring, managing, motivating, coaching and mentoring.
- Oversee testing on water, materials, components, personnel and the environment to detect microorganisms and to obtain information on types and levels of microbial contamination.
- Determine impact of microorganisms on processes / products and evaluate the effectiveness of contamination control strategies on the manufacturing environment.
- Communicate the status of microbiological testing and results trending to QA, Manufacturing, Validation and other departments as needed.
- Draft and review technical investigations, protocols and reports; offer conclusions and recommendations based upon study outcomes.
- Actively participate in laboratory and environmental investigations and identify / assess corrective and preventive actions.
- Draft, review and approve protocols, reports and procedures.
- Perform method development and validation activities as required, including all associated protocols and reports.
- Participate in quality audits of contract laboratories and other vendors to ensure third parties meet all requirements for qualification.
- Oversee or coordinate the required contract testing of samples and manage the receipt of test results.
- Establish and maintain good practices with regards to testing processes and data management.
- Ensure that trending is performed on a routine basis and that periodic summaries are compiled, maintain laboratory logbooks and other documents to ensure GDP.
- Develop training requirements, ensure all Microbiology personnel are adequately trained and qualified to perform the assigned job functions.
- Perform all job responsibilities in compliance with applicable regulations, standard operating procedures, and industry best practice.
- Support Agency, customer and vendor audits as needed.
- Exhibit professional behavior with both internal/external business associates that reflects positively on the company and is consistent with the company's policies and practices.
- Perform all other tasks, projects, and duties as assigned.
DESIRED SKILLS & ABILITIES
- A thorough understanding of cGMP, FDA guidelines and multinational regulatory standards is required.
- Experience and expertise in aseptic manufacturing of regulated products is required.
- Ability to interpret and relate Quality standards for implementation and review.
- Knowledge of Quality Control, Contamination Control, and Microbiology principles and procedures in a pharma, biopharma, and/or biotech manufacturing environment.
- Ability to portray an appropriate level of integrity and professionalism at all times.
- Ability to communicate effectively with management, staff, regulators and client representatives, in both written and verbal forms.
- Ability to complete tasks accurately and according to established timelines.
- Demonstrated management ability with a proven track record of leading teams to meet objectives.
- Ability to make sound decisions about scheduling, allocation of resources and managing priorities.
- Proficiency in both written and verbal communication and presentations.
- Energetic, self-motivated, organized individual who is accustomed to working in a deadline-focused, high-pressure entrepreneurial environment.
- Results oriented and efficient.
- Creative and open-minded who fosters an environment in which sharing of ideas is encouraged.
- Ability to work closely with a diverse customer base (internally and externally).
- Ability to work well in a cross-functional team environment.
- Must have proficient computer skills in Microsoft Word, Excel and Outlook.
Qualified candidates have attained a Bachelors Degree in Life Sciences (microbiology preferred) or a related field and have a minimum of 8-10 years work experience, at least 2 of which include prior management/leadership experience and were in a parenteral manufacturing environment.
GRAM supports Equal Opportunity Employment