JOB SUMMARY

Reporting to the Microbiology Supervisor, the Microbiologist ensures that the Microbiology laboratory provides the highest quality analytical support for manufacturing while ensuring compliance with protocols, cGMP and safety regulations in aseptic environmental monitoring and various microbial testing. Acts as backup for the Microbiology Supervisor in their absence.
Shift: Monday-Friday, 5:00am-1:30pm (1st Shift)

JOB DUTIES

• Ensures that microbiology testing for raw materials and finished product is completed in a timely and accurate manner to meet product manufacturing requirements for manufacture and release.
• Ensures that all work is carried out in compliance with company Safety policies, Good Manufacturing Practices (GMP/GLP) and Standard Operating Procedures (SOPs) and meets housekeeping and cleanliness standards.
• Develops and validates testing methods used in routine analysis of incoming raw materials and finished products.
• Reviews all documentation for accuracy and completeness and ensures that it’s in compliance with current GMPs/GLP, Good Documentation Practices, SOPs and company policies.
• Specialize in the Aseptic manufacturing environmental monitoring and various microbial testing and provides training and feedback to the Microbiologists as required.
• Specialize in various microbial testing such as Sterility test, BET, Bioburden, GPT, Microbial Assays and Identification.
• Assistants as needed in the preparation of investigations relating to deviations in raw materials, finished products and environmental monitoring. Provides technical support in evaluating incidents and interventions during filling operations.
• Communicates to the Manager any corrective actions that need to be taken in response to excursions in controlled environmental conditions and makes recommendations.
• Responsibility includes to develop validation protocols, write related project reports. In addition, update laboratory documentation, SOPs and test methods as required.
• Participates in technical studies for research and development projects, as assigned or scheduled.
• Supports microbiology validations and other projects and offers technical expertise for Microbiology investigations. Assists validation in coordination of activities for media fills.
• Revises laboratory Standard Operating Procedures as required.
• Participates in internal and external audits as required. Acts as a subject matter expert and may assist in providing gown training for production staff.
• Other duties as assigned.
• Might need to stay longer than you schedule shift to meet the business requirement.
  At Bimeda we are committed to fostering an inclusive, barrier-free and accessible environment. Part of this commitment includes arranging accommodations to ensure an equitable opportunity to participate in the recruitment and selection process. If you require an accommodation, we will work with you to meet your needs. The job posting is available in an accessible format upon request by contacting the Human Resources Manager.

WHAT YOU BRING TO THE ROLE

• 3-5 years of experience in a regulated pharmaceutical industry including Quality Assurance.
• Specializes in Aseptic environment monitoring and various microbial testing.
• BSc degree in Microbiology, Biology or related field.
• Knowledge of Aseptic Environmental monitoring, various microbial testing, cGMP, Quality Systems, Drug Regulatory Affairs, Stability protocols and systems, manufacturing and packaging processes.
• Must possess apparent microbiologist qualities to be able to comfortably and successfully interface and communicate with all levels internally and externally.
• Effective communication skills.

COMPETENCIES REQUIRED FOR THE ROLE

FOSTERING COLLABORATION/TEAMWORK is the ability to work jointly with others or together especially in an intellectual endeavor; the ability and desire to work cooperatively with others on a team; as a team leader, the ability to demonstrate interest, skill, and success in getting groups to learn to work together. Builds partnerships for global performance. Respects others.
EFFECTIVE COMMUNICATION is the ability to convey information to another effectively and efficiently, to listen – help facilitate sharing of information between people. It is about understanding the emotional intention behind the information. The ability to express oneself clearly in conversations, confirm understanding, communicate using data and facts. Exhibit willingness to listen and show respect for oneself and others in interactions with others. express oneself clearly in verbal and business writing.
LEADERSHIP is the ability of an individual to influence or inspire followers or other members of the organization; to enhance others’ commitment to their work and to a high -performance culture. Provide motivational support, and the ability to develop and communicate goals in support of the business mission. Provides direction with purpose and alignment to Company vision and values.
THOROUGHNESS/DETAIL ORIENTED ensuring that one’s own and others’ work ad information are complete and accurate; carefully preparing for meetings and presentations following up with others to ensure that agreements and commitments have been fulfilled.
DEALING WITH AMBIGUITY the ability to be comfortable with change and uncertainty. The ability to deal with fuzzy problems with limited data and with no clear solutions. The ability to juggle several projects or to not bring closure to one project because of business changing needs.