... biotech companies of all sizes, we play a vital role in the global pharmaceutical industry. Our ... Regular presence in GMP manufacturing and cleanroom environments with proper gowning. * Occasional ...
Quick apply
... biotech companies of all sizes, we play a vital role in the global pharmaceutical industry. Our ... Regular presence in GMP manufacturing and cleanroom environments with proper gowning. * Occasional ...
... biotech companies of all sizes, we play a vital role in the global pharmaceutical industry. Our ... Regular presence in GMP manufacturing and cleanroom environments with proper gowning. * Occasional ...
... biotech companies of all sizes, we play a vital role in the global pharmaceutical industry. Our ... Regular presence in GMP manufacturing and cleanroom environments with proper gowning. * Occasional ...
... biotech companies of all sizes, we play a vital role in the global pharmaceutical industry. Our ... Maintains cleanroom environments to cGMP requirements * Develops and manages departmental goals and ...
... biotech companies of all sizes, we play a vital role in the global pharmaceutical industry. Our ... Maintains cleanroom environments to cGMP requirements * Develops and manages departmental goals and ...
... biotech companies of all sizes, we play a vital role in the global pharmaceutical industry. Our ... Prolonged periods of standing, walking, or working in a cleanroom environment. * Ability to wear ...
Quick apply
... biotech companies of all sizes, we play a vital role in the global pharmaceutical industry. Our ... Prolonged periods of standing, walking, or working in a cleanroom environment. * Ability to wear ...
... biotech companies of all sizes, we play a vital role in the global pharmaceutical industry. Our ... Maintains cleanroom environments to cGMP requirements * Develops and manages departmental goals and ...
Quick apply
... biotech companies of all sizes, we play a vital role in the global pharmaceutical industry. Our ... Maintains cleanroom environments to cGMP requirements * Develops and manages departmental goals and ...
... servicesto pharma and biotech companies of all sizes, we play a vital role in the global ... Prolonged periods of standing, walking, or working in a cleanroom environment. * Ability to wear ...
... servicesto pharma and biotech companies of all sizes, we play a vital role in the global ... Prolonged periods of standing, walking, or working in a cleanroom environment. * Ability to wear ...
Biotech Cleanroom information
What is a biotech cleanroom?
A Biotech Cleanroom is a specially designed, controlled environment used in biotechnology labs and manufacturing facilities to minimize contamination from dust, microbes, or other airborne particles. These rooms maintain strict temperature, humidity, and particle count standards to protect sensitive biological samples and processes. Workers in biotech cleanrooms follow rigorous gowning and hygiene protocols, and equipment is regularly sterilized. Cleanrooms are essential in producing pharmaceuticals, medical devices, and other biotech products that require high levels of purity and safety.
What are the key skills and qualifications needed to thrive as a biotech cleanroom technician?
To thrive as a Biotech Cleanroom Technician, you need knowledge of aseptic techniques, good laboratory practices (GLP), and a background in biology or biotechnology, often with an associate’s or bachelor’s degree. Familiarity with cleanroom protocols, environmental monitoring equipment, and compliance systems like GMP (Good Manufacturing Practice) is typically required. Attention to detail, reliability, and effective communication are critical soft skills for maintaining sterile environments and following strict procedures. These skills ensure product safety, regulatory compliance, and consistent quality in sensitive biotech manufacturing processes.
What are some common challenges faced when working in a biotech cleanroom environment?
One of the main challenges in a biotech cleanroom is maintaining strict adherence to contamination control protocols while performing complex tasks. Employees must follow rigorous gowning procedures, regularly sanitize equipment, and be vigilant about minimizing particle generation. The controlled environment can feel restrictive due to specialized attire and limited personal items, but it's essential for ensuring product quality and safety. Teamwork and clear communication are crucial, as tasks often require coordination with colleagues to maintain workflow efficiency and compliance with regulatory standards.
What is the difference between Biotech Cleanroom vs Laboratory Technician?
| Aspect | Biotech Cleanroom | Laboratory Technician |
|---|---|---|
| Required Credentials | Cleanroom certification, life sciences training | Associate degree or relevant certification, lab safety training |
| Work Environment | Controlled cleanroom environment, strict contamination control | Standard laboratory setting, varied equipment |
| Industry Usage | Biotech manufacturing, pharmaceutical production | Research labs, clinical testing |
Biotech Cleanroom specialists focus on maintaining contamination-free environments for biotech and pharmaceutical manufacturing, requiring specialized cleanroom protocols. Laboratory Technicians support research and testing in general lab settings. While both roles require scientific knowledge, cleanroom roles emphasize contamination control and certification, whereas lab technicians focus on testing and data collection.
What are popular job titles related to Biotech Cleanroom jobs in Tennessee?
For Biotech Cleanroom jobs in Tennessee, the most frequently searched job titles are:
What job categories do people searching Biotech Cleanroom jobs in Tennessee look for?
The top searched job categories for Biotech Cleanroom jobs in Tennessee are:
What cities in Tennessee are hiring for Biotech Cleanroom jobs?
Cities in Tennessee with the most Biotech Cleanroom job openings:
QA Specialist - On the Floor Support (2nd Shift, 3rd Shift, & Weekend Shift)
Nashville, TN • On-site
Full-time
Re-posted 28 days ago
Job description
Headquartered in Nashville, TN – one of the fastest-growing and most exciting cities in the United States – August Bioservices is a privately-owned, high-growth, and high-impact Contract Development Manufacturing Organization (CDMO). As a US-based outsourcing partner that provides a wide array of expert drug discovery, drug formulation, and drug manufacturing services to pharma and biotech companies of all sizes, we play a vital role in the global pharmaceutical industry. Our work is instrumental in helping to develop molecules today that can become the life-changing therapies of tomorrow. To support our growth plans, August is investing significant capital in a two-phase expansion project – including building a new state-of-the-art facility adjacent to our current facility. For those seeking dynamic opportunities, rewarding career paths and a chance to make a difference in global health, come grow with August!
We are seeking a proactive QA Specialist to provide real-time quality oversight across manufacturing, packaging, inspection, and warehouse operations. The role ensures cGMP compliance, supports production activities, and promotes a strong quality culture. The ideal candidate is detail-oriented, hands-on, and able to provide guidance to operators while maintaining inspection readiness.
Responsibilities - Maintain a daily presence on the production floor to provide real-time QA support and guidance.
- Ensure adherence to batch records, SOPs, and validated procedures during manufacturing, packaging, and inspection activities.
- Perform QA line clearances, in-process checks, and AQL inspections, and support visual inspection and automated inspection processes.
- Act as a Designated Observer for controlled substance handling, ensuring compliance with internal and regulatory requirements.
- Routinely walk through production, lab, and warehouse areas to assess GMP compliance and escalate issues as needed.
- Verify labeling issuance, reconciliation, and documentation to ensure proper handling of materials and finished products.
- Provide on-the-floor coaching and guidance to operators, reinforcing GMP compliance and best practices.
- Collaborate with Manufacturing and Planning teams to prioritize lot disposition, minimize downtime, and support operational flow.
- Monitor cleaning, sanitization, and environmental controls prior to critical operations.
- Promote a quality-focused culture by sharing lessons learned and encouraging proactive issue identification.
- Maintain knowledge of deviation, OOS/OOT, and CAPA processes to support investigations if required.
- Assist in gathering facts, reviewing documentation, and providing QA input when deviations occur on the floor.
- Understand root cause analysis tools (5 Whys, Fishbone, FMEA) to support quality discussions.
- Review, revise, and proofread GMP documentation, including batch records, SOPs, and logbooks.
- Support document control processes and ensure training documentation is correctly linked to controlled systems.
- Ensure compliance with regulatory standards (FDA, ICH, DEA) and Good Documentation Practices.
- Conduct routine walk-throughs to maintain inspection readiness.
- Support internal audits and regulatory inspections by providing floor-level guidance and documentation as needed.
- Bachelor’s degree in a scientific discipline or equivalent experience.
- 2–5 years in a GMP-regulated environment, with experience in on-the-floor QA support.
- Knowledge of cGMPs, FDA/ICH regulations, and QA documentation practices.
- Familiarity with Master Control or electronic quality systems preferred.
- Strong communication, problem-solving, and interpersonal skills.
- Regular presence in GMP manufacturing and cleanroom environments with proper gowning.
- Occasional off-shift, weekend, or extended coverage may be necessary.
Preferred Qualifications:
- Experience with automated visual inspection processes.
- Knowledge of controlled substance handling.
- Prior involvement in regulatory inspections.
ADA Accommodation Notice
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Physical Requirements
- Ability to safely wear and work in a PAPR hood and associated equipment weighing approximately 2 to 3 pounds during assigned tasks.
- Ability to perform sustained physical activities, including standing, walking, bending, reaching, lifting, and handling manufacturing equipment while wearing required respiratory protection and personal protective equipment (PPE).
- Ability to wear and operate a Powered Air-Purifying Respirator (PAPR) for extended periods, up to 4 to 6 hours per shift, while performing manufacturing, equipment cleaning, and sanitization activities.
- Ability to wear required PPE, including pharmaceutical gowning, respiratory protection, safety glasses, chemical-resistant gloves, and additional protective equipment as required by operational and safety procedures
2nd shift: 3:00pm - 11:30pm , Monday - Friday
3rd shift: 11:00pm - 7:30am , Sunday - Thursday
Weekend Day shift: 7:00 am - 7:00 pm, Friday - Sunday
At August Bioservices, Our Credo is our culture. Everything we do, we do with great care. We believe in the promise of discovery and the power of science to transform lives. We assert that excellence is not a static destination, but a standard, and an every-day measuring stick of our advancement. We aspire to unlock the potential in every person, every process and every molecule – from start to finish. We are committed to doing the right thing the first time and every time, meeting or exceeding all regulatory requirements. We strive to be exceptional, preferred and indispensable partners for our customers; responsible and engaged citizens within our communities; and active, mindful stewards of our environment.
We are August Bioservices. We are pointing the way forward. If this sounds like your kind of working environment, we want you on our team!
August Bioservices is an equal opportunity employer and values diversity. All aspects of employment including the decision to hire, promote, discipline, or discharge, will be based on merit, competence, performance, and business needs. August Bioservices does not discriminate on the basis of any status protected under federal, state, or local law.
We may use artificial intelligence (AI) tools to support parts of the hiring process, such as reviewing applications, analyzing resumes, or assessing responses and identifying potential inconsistencies or verification signals in application materials based on available information. These tools assist our recruitment team but do not replace human judgment. Final hiring decisions are ultimately made by humans. If you would like more information about how your data is processed, please contact us.
About August Bioservices
Sourced by ZipRecruiter
Industry
Pharmaceutical and medicine manufacturing
Company size
51 - 200 Employees
Headquarters location
Nashville, TN, US
Year founded
2017