ROTATION #1 – Microbiology
POSITION SUMMARY
The Analyst 1 QC Microbiology works both independently and with the team to perform routine and non-routine microbiological testing and Microbiology laboratory maintenance functions.

ESSENTIAL FUNCTIONS
• Carry out responsibilities in accordance with the organization’s policies, procedures, and state, federal and local laws.
• Ensure compliance with current Good Manufacturing Procedures (cGMP), USP, EU and other global regulatory requirements at all times
• Follow directions well; work cooperatively as an individual contributor and as a team member.
• Communicate effectively with peers, department management and cross-functional peers.
• Collect and test water samples from water and steam ports used to support and manufacture drug products.
• Collect environmental monitoring samples in controlled areas for viable and non-viable particulates.
• Document laboratory test results on worksheets utilizing Good Documentation Practices.
• Document environmental monitoring test results on spreadsheets and prepare data for trend analysis and monthly reports.
• Participate in aseptic process qualifications, such as aseptic gowning and media fills.
• Assist with development of Aseptic training for site Aseptic and Controlled Area employees
• Prepare microbiological testing media .used in microbiological testing of bulk pharmaceutical raw materials, In Process and Finished product.
• Perform routine Microbiological Testing such as Bioburden, Bacterial Endotoxin, and Sterility Testing on water, bulk pharmaceutical raw materials, In process and Finished drug products.
• Perform Quality Control testing of incoming laboratory reagents, microbiological testing media, and biological indicators.
• Under the guidance of Supervision supports special project work.
• Support testing (Biological Indicator and BET) for the Validation Department Depyrogenation and Sterilization qualification/ validation protocols of the manufacturing equipment.
• Perform microbial isolation techniques and perform Gram stain identifications.
• Prepare microbial isolates for identification at approved contract laboratory.
• Provide review input for revision to controlled documents such as Standard Operating Procedures and Controlled Forms.
• Record and interprets data results.
• Perform other duties as assigned.

ROTATION #2 – Aseptic Manufacturing - TBD
POSITION SUMMARY
The Associate Specialist, supports all aspects of department related technical needs and serves as a liaison to other departments as needed in support of projects, document changes, and investigations. The incumbent will support training, documentation, deviations, change controls, standard operating procedures, protocols, complaints and policies. The Specialist will also be responsible for participating and learning all aspects for the aseptic department functions in support of Abraxane processing. Supporting activities in Operational Excellence and Continuous Improvement initiatives ensuring the proper systems, equipment, materials, and other resources are appropriately scheduled and available in order to meet production goals. This position may require overtime, shift work, and flexibility in scheduling of “set” shift hours at times, based on production or department needs.

ESSENTIAL FUNCTIONS
• Support investigation reports for department/site related deviations.
• Compile department/site trending information.
• Generate change control requests, as necessary, to support projects and routine production needs.
• Understand and follow department and site SOPs.
• Communicate effectively with department and cross-functional peers; Participate in project teams,
• Performs technical data review.
• Facilitate protocol review, including conducting research into industry standards/regulatory guidelines for protocol approach/rationale acceptance.

EDUCATION/EXPERIENCE REQUIREMENTS
• Is in senior year of college and will be obtaining Bachelors Degree or has recently graduated and has maintained a minimum 3.25 GPA on a 4.0 Scale.
• Degree in Biological Sciences, preferably in Microbiology.
• Has a proven history of academic achievement, extra-curricular activities and leadership skills.
• Demonstrates strong analytical and communications skills.
• Has prior work experience either through on-campus, off-campus or volunteer opportunities.
• Previous sterile pharmaceutical manufacturing or sterile pharmaceutical development experience or course work preferred.
• Proficiency with Visio & MS Project preferred.
• Possesses excellent verbal and written communication, organization and time management skills.

Computer/Software Skills
Requires proficiency in basic MS Word, Outlook, Excel
Compliance Knowledge
Requires general knowledge of cGMP, OSHA, DEA, USP and EP
General Competencies
Requires flexibility and ability to multi-task
Requires strong written and verbal communication skills
Requires strong organizational and time management skills
Requires strong teamwork and facilitation skills
Written Communication
Requires ability to interpret / write general business documents
Requires ability to interpret / write technical documents
Problem Solving
Requires ability to solve routine problems
Level of Supervision
Requires direct supervision
Impact of decisions
Impacts one department
Impacts multiple departments

Qualifications
EDUCATION/EXPERIENCE REQUIREMENTS
• Is in senior year of college and will be obtaining Bachelors Degree or has recently graduated and has maintained a minimum 3.25 GPA on a 4.0 Scale.
• Degree in Biological Sciences, preferably in Microbiology.
• Has a proven history of academic achievement, extra-curricular activities and leadership skills.
• Demonstrates strong analytical and communications skills.
• Has prior work experience either through on-campus, off-campus or volunteer opportunities.
• Previous sterile pharmaceutical manufacturing or sterile pharmaceutical development experience or course work preferred.
• Proficiency with Visio & MS Project preferred.
• Possesses excellent verbal and written communication, organization and time management skills.