Document Control Associate Jobs in Branford, FL (NOW HIRING)

Position Overview:

The QC Analyst - Microbiology will partner and collaborate with the manufacturing operations team to ensure environmental control of the aseptic and CGMP manufacturing facility. This position will support the day-to-day activities of the manufacturing and quality control group by performing lot release testing, routine environmental monitoring of the cleanrooms, utility monitoring of the CGMP utility systems, microbial assay testing, maintenance of laboratory supplies, routine EM/UM data trending, and coordination of samples from outside production facilities for release testing and result report generation.

Reports to: Director of Quality

Location: Alachua, FL 

Schedule: Monday - Friday, dayshift

Salary Range: $65,000 - $75,000

Key Responsibilities: 

• Routine activities include:
• Comply with all company policies, procedures, and SOPs. 
• Operate and maintain the lab in a neat and orderly way - following procedures and completing/maintaining appropriate records.
• Perform laboratory equipment maintenance and calibration as needed.
• Perform environmental monitoring (air, surface, and personnel) of the cleanrooms and laboratory in support of GMP manufacturing, to include off hours and weekends when required.
• Perform critical utility monitoring (water and compressed air).
• Execute growth promotion of microbiological media and qualification of commercially prepared organisms.
• Perform QC testing on raw materials and in-process products. Generate records in compliance with GMP requirements.
• Thorough and focused execution of laboratory testing (bioburden, endotoxin, plate reading, Biological Indicator testing, etc.).
• Thorough and focused execution of sterility testing, method verifications, and method suitability via the Celsis Advance II Rapid Microbial Detection System and USP <71>.
• Assist with qualification and validation of equipment and related processes.
• Assists in developing, troubleshooting, optimizing complex QC procedures according to regulatory requirements.
• Analyze, document, review and report experimental data in accordance with Strive Outsourcing requirements.
• Assist with data analysis and trending of EM and UM data to ensure a state of control.

• Provide support to the Manufacturing Operations team as needed:
• Assist with training of manufacturing associates on aseptic techniques
• Assist with environmental monitoring and assay related investigations
• Assist with the qualification of manufacturing associates in sterile gowning
• May require occasional early morning, late evening, and/or weekend work.
• Other activities as assigned

Qualifications:

• BS in a Biological Science field (Biochemistry, Microbiology, Immunology, Molecular Biology, Virology), or related field and 2+ years of applicable industry experience.
• Experience with cGMPs applicable to the pharmaceutical industry.
• Strong verbal/written and interpersonal communication skills as a team player and willing to work in an environment where individual initiative, collaboration and accountability are valued.
• Able to prioritize and manage through multiple complex processes/projects.
• Ability to define problems, collect data, establish facts, and draw valid conclusions.
• Analytical problem-solving and organizational skills.
• Ability to work independently and stay on task in a fast-paced environment without direct supervision.
• Adaptable and flexible in response to a dynamic operating environment.

Preferred Qualifications:

• Experience with the following microbiology tests: sterility, endotoxin, growth promotion, subculture techniques, environmental monitoring, bioburden, BI testing, compressed gas testing, etc.
• Experience in a compounding pharmacy or outsourced testing facility.

Position and compensation levels are commensurate with level of education and experience.

Role/Site Specific Requirements:

This position may also include the following:

• This role requires extended periods of standing and being on your feet.
• There may be periods of being in a sedentary position for a prolonged period of time.
• Applicants must be able to independently lift up to 20 pounds from a floor position to a waist level position with little to no mechanical assistance.
• Visual acuity such as: working with data & figures, viewing computer terminals, extensive reading, operating machinery, general observations of facilities, etc.

Exposure to the following:

• Use of personal protective equipment (gowns, gloves, face protection, other barrier equipment, etc.
• Handling, managing, disposing biohazardous, hazardous and non-hazardous waste (which can include: chemicals, universal and e-wastes, oil, aqueous wastewater, etc.).
• Working in laboratories & production rooms, waste holding areas, or other facilities where hazardous chemicals may be stored or handled.

The items described here are representative of those that must be met to successfully perform the essential functions of this job.