To apply directly for this position please visit our company careers page: https://signaturebiologics.hirecentric.com/jobs/231133-47231.html

Signature Biologics, as part of a suite of emerging biotechnology and research companies, focuses on the development and commercialization of regenerative based products. We have significant clinical experience working with human perinatal biologics internationally and we are currently developing products in the US.

Essential Duties and Responsibilities:

The Environmental Monitoring (EM) Analyst will support routine Environmental Monitoring of air, surface and clean utilities for manufacturing of in process and final product following current Good Manufacturing Practices.

Key Responsibilities:

· Collect and perform non-viable, viable air (active and passive), surface monitoring and personnel monitoring to support routine EM, in-process EM, process simulation, aseptic operator qualification and gowning qualification.

· Perform analysis of environmental monitoring test results according to SOPs and test methods

· Participate in quality testing for ongoing clinical trial support.

· Write, review and execute microbiological assays such as bioburden, endotoxin, gram stain, mold identification, growth promotion and plate enumeration as needed.

· Support EM data management including data entry, data verification, data download and generation of reports to support data trending.

· Provide guidance and training to junior staff or other departments as necessary.

· Write Standard Operating Procedures, Deviations, CAPAs, Change Controls, Test Methods and other departmental documents.

· Participate in investigations related to out of specification EM results.

· Assist with the setup and daily running of EM laboratory.

· Perform routine maintenance including support of calibration and sanitization of lab equipment and lab spaces.

· Track and support calibration of EM equipment.

· Coordinate shipping of EM samples to approved 3rd party vendor.

· Seek continuous improvement within EM related activities.

· Perform special projects as assigned.

Education and/or Work Experience Requirements:

· Associate degree or higher required. Preferred area of study in Microbiology, Biochemistry or related Science field, or equivalent combination of education and experience.

· Minimum of 2 years experience in Biotechnology, Pharmaceutical or Biopharmaceutical industry.

· Direct experience in GMP environment and aseptic technique preferred.

· Previous experience using GMP Quality Systems (ex. TrackWise, MasterControl) preferred.

· Excellent verbal and written communication skills with the ability to collaborate across multiple teams and projects.

· Ability to multi-task and prioritize responsibilities.

· Excellent computer proficiency (MS Office – Word, Excel and Outlook)

· Must be able to work under pressure and meet deadlines, while maintaining a positive attitude and providing exemplary work product.

Physical Requirements:

· Ability to lift 50 lbs. and work in controlled space laboratory environment.

· Ability to climb ladders to reach high sampling sites.

· Ability to reach above the shoulder and bend to be able to gown.

· Ability to wear full level 3 gowning for extended periods to support EM monitoring in Cleanrooms.

· Must be able to work while standing for extended periods.

To apply directly for this position please visit our company careers page: https://signaturebiologics.hirecentric.com/jobs/231133-47231.html

Job Type: Full-time

Pay: $20.00 - $22.00 per hour

Expected hours: 40.00 per week

Benefits:

• 401(k)
• 401(k) matching
• Dental insurance
• Health insurance
• Life insurance
• Paid time off
• Parental leave
• Vision insurance

Experience level:

• 2 years

Schedule:

• 8 hour shift

Work setting:

• In-person
• Office

Application Question(s):

• Are you currently located in the DFW area?
• Based on the job description, why do you believe you are a competitive candidate for this position?
• Have you worked in an position that requires you to use aseptic technique including full gowning?

Experience:

• Biotechnology, Pharmaceutical or Biopharmaceutical industry: 2 years (Required)
• GMP Quality Systems (ex. TrackWise, MasterControl): 1 year (Required)

Ability to Relocate:

• Irving, TX 75063: Relocate before starting work (Required)

Work Location: In person