Atcc Microbiology Jobs in Usa

Position Overview

A hospital-based clinical laboratory in Central PA is seeking a Microbiology Laboratory Director to provide scientific, operational, and regulatory leadership for a high-complexity microbiology laboratory. This role is responsible for overseeing laboratory operations, ensuring compliance with regulatory standards, guiding test development and validation, and supporting clinical teams with microbiology expertise.

The ideal candidate will bring strong leadership skills, a commitment to quality and regulatory compliance, and experience managing microbiology testing in a clinical laboratory environment.

Key Responsibilities

Laboratory Leadership & Oversight

• Provide medical and scientific direction for all microbiology laboratory operations
• Oversee daily laboratory activities to ensure quality, accuracy, and efficiency
• Support and mentor laboratory supervisors, technologists, and technical staff
• Collaborate with hospital leadership and clinical teams on laboratory strategy and patient care initiatives

Regulatory Compliance & Quality

• Ensure laboratory compliance with CLIA, CAP, and applicable regulatory requirements
• Maintain and oversee quality management programs, including proficiency testing and quality assurance initiatives
• Review and approve validation and verification studies for new assays and instrumentation
• Participate in regulatory inspections and implement corrective actions when necessary

Test Development & Technical Expertise

• Provide guidance for microbiology test development, validation, and implementation
• Evaluate new technologies, platforms, and workflows to enhance laboratory services
• Review and approve standard operating procedures and technical documentation

Clinical & Operational Collaboration

• Serve as a subject matter expert for microbiology testing and infectious disease diagnostics
• Partner with infectious disease physicians, pharmacy, and infection prevention teams
• Support antimicrobial stewardship initiatives and clinical decision-making

Qualifications

Education

• Ph.D. in Microbiology, Clinical Microbiology, or a related field

Experience

• 2–5 years of clinical microbiology laboratory experience in a high-complexity setting
• Experience in hospital or health system laboratories preferred
• Prior leadership or supervisory experience is highly desirable

Certifications (Preferred)

• ABMM (American Board of Medical Microbiology) or eligibility preferred

Skills & Competencies

• Strong knowledge of clinical microbiology methodologies and instrumentation
• Familiarity with regulatory standards including CLIA and CAP
• Excellent leadership, communication, and organizational skills
• Ability to collaborate effectively with clinical and administrative stakeholders

Compensation & Benefits

• Salary Range: $180,000 – $230,000 annually
• Comprehensive benefits package including:
• Medical, dental, and vision insurance
• Retirement plan with employer contribution
• Paid time off and holidays
• Continuing education support
• Relocation assistance may be available

About us:

At Lighthouse Lab Services, we offer solutions to help start, grow, and run clinical laboratories. Our recruiting team has over 21 years of proven success placing job seekers in positions ranging from entry-level Medical Technologists to seasoned Laboratory Directors. We recruit nationwide, for permanent and travel positions with clients ranging from small hospitals to large reference laboratories.

It is the policy of Lighthouse Lab Services to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state or local law. Lighthouse Lab Services is committed to working and providing reasonable accommodation to individuals of all abilities, including persons with disabilities.

If at any time during the application process, you need an accommodation, please contact for assistance.

Lighthouse Lab Services | 844-974-1929 | LLS3

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• Perform environmental monitoring of cleanrooms.
  
• Collect water samples according to schedule and ensure timely testing.
  
• Perform and review microbiological assays including:
  
  • 
    
  • Gram Stain
    
  • Endotoxin
    
  • Sterility testing
    
  • Microbial identification
    
  • Bioburden testing
    
  • Plate reading
    
  
  
  
• Conduct utility monitoring for purified water systems and compressed gases.
  
• Perform data entry, trending analysis, and prepare reports or slides for management review.
  
• Assist with investigations related to Out-of-Specification (OOS) results and manage deviations related to microbiological procedures.
  
• Perform routine maintenance of laboratory equipment and lab areas.
  
• Review and approve final product release test results.
  
• Perform additional duties as assigned.
  

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• Associate Degree (AA) with 1+ year of experience in a Microbiology Lab or Environmental Monitoring, OR
  
• High School Diploma with 2+ years of experience in a Microbiology Lab or Environmental Monitoring.
  

• 
  
• Experience with microbiological techniques, including:
  
  
  • 
    
  • Environmental air monitoring
    
  • Water testing
    
  • Surface monitoring
    
  
  
  
• Experience with aseptic techniques and cleanroom operations.
  
• Ability to gown for entry into aseptic manufacturing areas and lift approximately 25 lbs.
  
• Knowledge of GMP, SOPs, and quality control processes in commercial manufacturing.
  
• Proficiency in MS Word, Excel, PowerPoint, and other computer applications.
  
• Strong interpersonal, verbal, and written communication skills.
  
• Ability to work in a fast-paced environment with minimal supervision and adapt to changing priorities.
  
• Flexibility to work overtime or adjust schedules as required.
  

Legend Biotech is a global biotechnology company dedicated to treating, and one day curing, life-threatening diseases. Headquartered in Somerset, New Jersey, we are developing advanced cell therapies across a diverse array of technology platforms, including autologous and allogenic chimeric antigen receptor T-cell, T-cell receptor (TCR-T), and natural killer (NK) cell-based immunotherapy. From our three R&D sites around the world, we apply these innovative technologies to pursue the discovery of safe, efficacious and cutting-edge therapeutics for patients worldwide.

Legend Biotech entered into a global collaboration agreement with Janssen, one of the pharmaceutical companies of Johnson & Johnson, to jointly develop and commercialize ciltacabtagene autolecuel (cilta-cel). Our strategic partnership is designed to combine the strengths and expertise of both companies to advance the promise of an immunotherapy in the treatment of multiple myeloma.

The Sr. Manager, QC Microbiology, is an exempt level position with responsibilities for managing the operation and workflow of the quality control microbiology laboratories in support of cell therapy manufacturing. This includes hiring, development and performance management of staff, reviewing/approving laboratory test data, developing and implementing microbiology procedures and methods, supporting laboratory investigations and ownership of various QC microbiology department projects. The role develops and implements long-term strategies and manages a team of people leaders and technical professionals within the QC department based on assigned work, direction, coaching and developing capabilities

• Ensuring adequate training (skills-based, cGMP and safety) of people leaders and associates within the department.
• Manage Raw material, in-process, environmental monitoring/utility, product release, and stability testing.
• Manage and support Investigation of laboratory non-conformances (events, deviations, and invalid assays).
• Maintenance, calibration and qualification of laboratory instruments and equipment.
• Test method verification, qualification, validation and/or transfer activities in the QC Micro laboratories.
• Process Performance Qualification and Continued Process Verification activities associated with QC microbiology laboratory testing.
• Providing expertise in troubleshooting complex laboratory issues and demonstrating strong reasoning skills in support of ongoing laboratory investigations.
• Maintain detailed knowledge of industry guidelines/trends, regulatory requirements, and applicable pharmacopeia while remaining current in on-the-job training requirements.
• Collaborate with Quality Assurance, Manufacturing, Technical Operations, Engineering and Maintenance to support business needs.
• Contribute to global strategies related to QC laboratories which align with compliance and business objectives as well as the overall corporate vision.
• Manage departmental budget and resources; prepare staffing plans. Make adjustments to roles and responsibilities of department to meet business needs.
• Perform tasks in a manner consistent with the safety policies, quality systems and cGMP requirements.
• Monitor QC method performance through trending analysis for on QC generated test results.
• Represent department during internal and external audits.
• Job duties performed routinely require exposure to and handling of biological materials and hazardous chemicals.
• Works in a collaborative team setting with quality counterparts that include Quality Assurance, Manufacturing Operations, Technical Operations, Engineering and Maintenance, Supply Chain and Planning.
• Other duties will be assigned, as necessary.
  

• A minimum of a Bachelor’s Degree in Science, Biology or equivalent technical discipline is required.
• A Minimum of 12 to 14 years relevant work experience is required. It is preferable that the candidate has experience working in an aseptic manufacturing facility, preferably in microbiology quality control laboratory, quality assurance, or cell therapy. A minimum of 3-5 years of leadership experience is also required.
• Experience working with Quality systems is required.
• Extensive knowledge of chemical, biochemical and microbiological concepts is required.
• Ability to apply basic and advanced mathematical concepts (including statistics) in the evaluation of laboratory data is required.
• Knowledge of cGMP regulations and FDA/EU guidance is required.
• Comfortable with speaking and interacting with inspectors.
• Good written and verbal communication skills are required.
• This position may require up to 10% domestic or international travel as business demands.
• Detailed knowledge and understanding of current Good Manufacturing Practices (cGMP) and current Good Tissue Practices (cGTP) related to CAR-T manufacturing or cell processing.
• Proven people management and leadership experience are required.
• In-depth knowledge and experience in biopharmaceutical analysis method verification is preferred.
• Experience in microbiological test methods and EM is preferred.
• Ability to quickly process complex information and often make critical decisions with limited information.
• Ability to handle multiple priorities on a daily basis while being flexible and responsive to frequently shifting priorities.
• Proficient in applying excellence tools and methodologies.
• Ability to summarize and present results, and experience with team-based collaborations is a requirement.
• Experience in developing and setting long-term objectives for individual and teams.
• Have a high sense of responsibility and professionalism with excellent organizational skills, analytical judgment and communication skills.
• Able to work cross functionally and under pressure.
  
  

The base pay range below is what Legend Biotech USA Inc. reasonably expects to offer at the time of posting. Actual compensation may vary based on experience, skills, qualifications, and geographic location. The company reserves the right to modify this range as needed and in accordance with applicable laws.Other Types of Pay: Performance-based bonus and/or equity is available to employees in eligible roles.Benefits and Paid Time Off: Medical, dental, and vision insurance as well as a 401(k) retirement plan with a company match that vests fully on day one. We offer eight (8) weeks of paid parental leave after just three (3) months of employment, and a paid time off policy that includes vacation time, personal time, sick time, floating holidays, and eleven (11) company holidays. Additional voluntary benefits include flexible spending and health savings accounts, life and AD&D insurance, short- and long-term disability coverage, legal assistance, and supplemental plans such as pet, critical illness, accident, and hospital indemnity insurance. We also provide voluntary commuter benefits, family planning and care resources, well-being initiatives, and peer-to-peer recognition programs; demonstrating our ongoing commitment to building a culture where our people feel empowered, supported, and inspired to do their best work.

Pay Range (Base Pay): : $142,146 USD - $186,567 USD

Please note: These benefits are offered exclusively to permanent full-time employees. Contractors are not eligible for benefits through Legend Biotech.

EEO Statement

It is the policy of Legend Biotech to provide equal employment opportunities without regard to actual or perceived race, color, creed, religion, national origin, ancestry, citizenship status, age, sex or gender (including pregnancy, childbirth, related medical conditions and lactation), gender identity or gender expression (including transgender status), sexual orientation, marital status, military service and veteran status, disability, genetic information, or any other protected characteristic under applicable federal, state or local laws or ordinances.

Employment is at-will and may be terminated at any time with or without cause or notice by the employee or the company.

Job Title: Microbiology Laboratory Technician

Location: Franklin Lakes NJ

Duration: 12+ Months Contract

Pay: $35/hr W2

Job Summary:

Reporting to a supervisor/manager or higher, the Technician 2- Microbiology associate will:

- Execute a variety of laboratory tasks related to microbiological testing of pharmaceutical products

- raw materials, and medical devices.

- Perform microbiological testing in a BioSafety Level-2 laboratory under GLP conditions.

Responsibilities:

- Perform routine and non-routine USP, ASTM, ISO, and CLSI based microbiological testing for anti-infective, antiseptic, or disinfectant efficacy (i.e., time-kill assay, MIC/MBC, sterility testing, microbial limits, bioburden).

- Execute testing following standard operating procedures in a BioSafety Level-2 Laboratory

- Assists in the qualification and validation of equipment and lab instruments including calibration under established procedures.

- Responsible for maintaining laboratory notebooks following good documentation practice (GDP),

- Good laboratory practices (GLP) and supports compliance with GLP.

- Works proactively and independently with minimal oversight/supervision to complete projects.

Education/Experience:

Bachelor of Science (BS) Degree in Microbiology/Biological Sciences/Chemistry.

Minimum of 1+ years of experience in a laboratory setting of microbiology or related industrial

Required Skills:

- Working either as part of a team and independently is required.

- Detail oriented and excellent organizational skills

- Ability to organize and prioritize work with limited guidance

- Experience working in a BioSafety Level-2 laboratory, academic or industrial

Preferred Skills:

- Experience performing microbiology testing in a GXP laboratory

- Experience working with LIMS data management software

Physical Demands:

Work for extended periods of time in front of a biological safety cabinet, Standing or sitting at a laboratory bench for extended periods of time, Able to lift 25 lbs, Wear PPE appropriate for a BSL-2 laboratory, Able to lift 25 lbs, Wear PPE appropriate for a BSL-2 laboratory

Work Environment:

BSL-2 Laboratory environment using personal protective equipment (PPE), where may encounter/use biological, chemical or human body fluid for testing and handle biohazardous waste. The Shift is a Hybrid Shift 12-8pm. Some weekend work may be required.

Title: QC Microbiology Technician

Location: Frederick, MD 21704

100% onsite

Duration: 12 months Contract

Shift: Wednesday - Saturday | 7:00 AM – 6:00 PM

Position Summary

• We are seeking a highly motivated individual to join as a QC Microbiology Technician in a commercial cell therapy production center located in Frederick, MD.

• You will work with the Quality Control team in supporting efforts in cancer immunotherapy manufacturing.

• This position provides Quality Control microbiological testing for clinical and commercial manufactured product and is responsible for product testing, microbial growth promotion testing, utility testing and environmental monitoring.

Responsibilities

• Perform environmental monitoring of cleanrooms.

• Collect water samples to ensure all samples are collected per schedule and tested on time.

• Perform and review microbiological assays such as Gram Stain, Endotoxin, Sterility, Microbial Identification, Bioburden and Plate Reading.

• Perform utility monitoring of purified water and compressed gases.

• Data entry and trend data as needed and prepare slides for management.

• Assist in investigations regarding out of specification (OOS) results and manage deviations related to microbiological procedures.

• Routine maintenance of laboratory equipment and lab spaces.

• Review and approve all final product release test results.

• Perform other duties as required.

Basic Qualifications

• AA Degree and 1+ years' experience in Microbiology lab/Environmental Monitoring OR

• HS Degree and 2+ years' experience in Microbiology lab/Environmental Monitoring.

Preferred Qualifications

• Experience in the application of microbiological techniques such as environmental air monitoring, water testing, and surface monitoring.

• Experience in aseptic techniques and clean room operations.

• Ability to gown for entry into aseptic core and supporting areas and lift approximately 25 lbs.

• Knowledge of GMP, SOPs and quality control processes for commercial manufacturing.

• Proficient in MS Word, Excel, PowerPoint and other applications.

• Excellent interpersonal, verbal and written communication skills.

• Comfortable in a fast-paced environment with minimal direction and able to adjust workload based upon changing priorities.

• Ability to be flexible with schedule and work overtime as needed.

POSITION TITLE: QC Microbiology Supervisor

Department: Quality

Reports To: Micro Manager

FLSA Status: Exempt (Salary)

Prepared By: Department Manager

QC Microbiology Supervisor

The Micro Supervisor’s main roles would be the day-to-day operation of the microbial lab and release of products. Communicates day-to-day laboratory activities with the Micro Manager.

Coordinates and approves all OOS & incident investigations, deviations, and NCRs. Ability to complete Phase I and II of OOS investigations.

FUNCTIONS OF THE JOB:

1. Behavior: Exhibit Team player qualities of cooperation and coordination; professional interaction in all business contacts, all day, every day.
2. Attendance: Present for work when scheduled is a mandatory function.
3. Safety: Compliance with all company safety rules, procedures, and guidelines is essential.
4. Develops, implements, and maintains quality specifications and standards for all raw materials, bulk and finished goods.
5. Oversees testing on all samples submitted for analysis, including stability, method development, and R&D support.
6. Trains and mentors Micro personnel on policies and procedures. Assign work tasks to lab members to ensure an efficient QC function.
7. Provides on-going supervision and career development path to Micro personnel. Conducts performance evaluations, assists employees in resolution of work-related problems. Provides coaching and leadership to all personnel.
8. Provides technical assistance and interface with other departments to improve efficiencies, work flow, and cut costs. Communicates effectively throughout the organization to ensure quality issues are addressed.
9. Develops and validates new methods and procedures. Communicates new procedures to others and ensures adequate training is conducted.
10. Advocates GMP & GLP regulations and ensures that all laboratory activities and documentation meet compliance standards.
11. Ensure compliance with all applicable regulatory requirements including FDA, EPA, DNR, BATF, and OSHA.
12. Actively participates in all safety programs.
13. Coordinate and approve all OOS & incident investigations, deviations, and NCRs. Ability to complete Phase I and II of OOS investigations.
14. Reviews and revises all laboratory policies, procedures, test methods, and job descriptions
15. Actively participates in cross functional teams to ensure quality standards are met.
16. Coordinates with QC staff to provide support to ensure raw materials, bulk and finished product meet OTC release timing.
17. Ensures all instruments and laboratory equipment are performing within calibration and adequately maintained to meet GMP & GLP regulations.
18. Maintains lab supplies.

ducation Requirements:

Bachelor’s degree in Microbiology or related field and 6 years microbiology laboratory experience.

Experience Requirements:

A minimum of 8 years in a leadership role in an OTC (over-the-counter) drug or medical device manufacturing facility, with a majority of that experience in a Microbiology Lab environment. Experience in representing an OTC company during customer audits including contract customers and 3rd party auditors. A comprehensive knowledge of the FD&C Act and 21 CFR Parts 210/211 & 11 along with industry required standards for pharmaceutical and OTC drugs. Superior communication and leadership skills required.

Competencies:

Project management, technical writing, data analysis, knowledge of Microbiology laboratory testing and practices, and knowledge of current Good Manufacturing Practices are mandatory.

Certificates, Licenses, Registrations: N/A

Travel: Very Minimal

Work Environment:

This job operates in a professional office environment. This role routinely uses standard office equipment such as computers, phones, photocopiers, filing cabinets and fax machines.

Physical Demands:

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.

While performing the duties of this job, the employee is regularly required to talk or hear. The employee frequently is required to stand; walk; use hands to finger, handle or feel; and reach with hands and arms.

Physical Demands: Occasionally lift boxes of product 5-40 lb. Frequently lift samples 1-5 l

Description

Ready for more than just a job? Build a career with purpose.

At Lactalis in the USA, we're committed to providing meaningful opportunities for our people to learn, grow, and thrive-whether you're just starting your journey with us or looking to take the next step in your career. From day one, we offer the tools and support to help you succeed.

As the world leader in dairy, Lactalis is a family-owned company with over 85,000 pragmatic and ambitious professionals across the globe. Each day, we're proud to produce award-winning dairy products that bring people together.

In the US, we proudly offer an unrivaled house of beloved brands, including Galbani Italian cheeses and ricotta, President specialty cheeses and butters, Kraft natural and grated cheeses, Breakstone's cottage cheese, Cracker Barrel, Black Diamond cheddar, and Parmalat milk. Our yogurt portfolio includes siggi's, Stonyfield Organic, Brown Cow, Oui, Yoplait, Go-Gurt, :ratio, Green Mountain Creamery, and Mountain High, along with a growing family of ethnic favorites like Karoun, Gopi, and Arz.

At Lactalis, we live by our core values-Ambition, Engagement, and Simplicity. We foster a workplace where innovation thrives, diverse perspectives are celebrated, and everyone's unique background and ideas are valued.

Even if you don't meet every qualification, we encourage you to apply. We want to hear about your PASSION, your STORY, and how your EXPERTISE can help us shape the future of dairy.

From your PASSION to ours

Lactalis American Group, part of the Lactalis family of companies, is currently hiring a microbiology Lab Tech II based in Nampa. The microbiology Lab Tech II supports the plant by promptly plating and reading samples all throughout the cheese-making process in a high-volume environment while maintaining a clean, organized, and stocked lab.

From your EXPERTISE to ours

Key responsibilities for this position include:

* Pick up samples at various locations throughout the plant and sort them for plating.

* Prepare samples for plating: weighing, diluting, stomaching, heating, etc.

* Prepare media: buffer, agar, broth, etc.

* Perform various plating methods: petrifilm, filtration, pour plate, direct plate, streaking, MPN.

* Read and accurately record various types of plates.

* Data entry: samples plated, tests performed, record results in various spreadsheets

* Communicate results to plant management via email, phone, face to face.

* Quality checks: temperatures on various equipment, autoclave sterilization, media pH, etc.

* Lab cleanup at the end of shift and various cleaning throughout the month.

* Perform other duties as requested by supervisor.

Requirements

From your STORY to ours

Qualified applicants will contribute the following:

Education

* High School Diploma required.

* Associate degree or higher preferred with degree in microbiology

* Microbiology class and/or at least one year of laboratory experience in basic microbiology

Experience

* Dairy industry experience preferred.

* Aseptic Technique

* Lab work

Specialized Knowledge

* GMP and GLP

Skills / Abilities

* Microsoft Office, including Excel

* Time Management; ability to consistently meet deadlines

* Team Player

* Dedicated work ethic

* Analytical Thinking

* Strong math skills

* Attention to detail

* Organization

* Strong written and verbal communication

At Lactalis, we offer a comprehensive Total Rewards Program with a variety of affordable benefits and coverage options. We support insurance costs significantly, contribute generously to retirement plans, and offer Paid Time Off from day one. We are committed to your professional growth, providing training and development opportunities, including Education Reimbursement. Join us and grow your career.

Lactalis is an equal employment opportunity employer. We will not discriminate against applicants with regard to any legally-recognized basis including, but not limited to: veteran status, race, color, religion, sex, national origin, age, marital status, sexual orientation, and physical or mental disabilities.

Become part of an inclusive organization with over 40,000 teammates, whose mission is to improve the health and well-being of the unique communities we serve.

This position is eligible for our Clinical Laboratory Incentive Program.

To learn more on the incentive program guidelines and eligible positions, visit Summary: This position has responsibilities in all the following sections of the Microbiology laboratory
- Central Processing, Bacteriology, Mycology, Mycobacteriology, and Special Microbiology.

Position schedule: Wed-Fri 10:00am-8:30pm AND every other weekend (Sat/Sun) 10:00am-8:30pm; Rotating Holidays Responsibilities include but are not limited to the following: Direct specimen processing and direct specimen Gram stains AFB processing and smears Rapid antigen testing – Cdiff, Strep A, Legionella, Mono, Crypto Rapid molecular/PCR testing – Vaginitis, RSV, Flu, Cdiff, Gram Positive Susceptibility, COVID testing Total Lab Automation instrumentation (BD Kiestra), plate reading and organism ID AFB and Fungal culture reading Susceptibility testing – automated and KB Quality control of instruments, reagents, and media Sendout testing Other Information Other information: Education Requirements: ● Associate's degree in Clinical Laboratory Science, Medical Laboratory Technician, Chemical Science, or Biological Science.

Licensure/Certification Requirements: ● If Associate's degree in Clinical Laboratory Science, Medical Laboratory Technician, then must be ASCP or AMT Board of Certification eligible and must receive BOC within a year.

● If Associate's degree in chemical or biological science, Medical Laboratory Technician (ASCP) or MLT (AMT) Board of Certification (BOC) required.

Professional Experience Requirements: ● None required.

Knowledge/Skills/and Abilities Requirements: Job Details Legal Employer: STATE Entity: UNC Medical Center Organization Unit: Microbiology Laboratory Work Type: Full Time Standard Hours Per Week: 40.00 Salary Range: $23.24
- $33.41 per hour (Hiring Range) Pay offers are determined by experience and internal equity Work Assignment Type: Onsite Work Schedule: Evening Job Location of Job: US:NC:Chapel Hill Exempt From Overtime: Exempt: No This is a State position employed by UNC Health Care System with UNC Health benefits.

If, however, you are presently an employee of another North Carolina agency and currently participate in TSERS or the ORP, you will be eligible to continue participating in those plans at UNC Health.

Qualified applicants will be considered without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, genetic information, disability, status as a protected veteran or political affiliation.

UNC Health makes reasonable accommodations for applicants' and employees' religious practices and beliefs, as well as applicants and employees with disabilities.

All interested applicants are invited to apply for career opportunities.

Please email if you need a reasonable accommodation to search and/or to apply for a career opportunity.

Job Title: QC Microbiology, Analyst I

Location: Westborough, MA

Zip Code: 01581

Duration:6 Months

Pay Rate: $33.33/hr

Keyword's: #Westboroughjobs; #Microbiologyjobs.

Start Date: Immediate

Job Description:

Essential Job Responsibilities:

* Attire gowning for Grade B/A manufacturing areas and collect EM samples for viable air, non-viable particulates, and surface viable samples.

* Perform QC testing of samples for bioburden, microbial identification, growth promotion, and Endotoxin analysis.

* Receive manufacturing samples for QC analysis, ship samples to the contract labs testing, review data for lot disposition.

* Read and Review routine EM plates, lab testing data, logbooks, and documents for product release and trend reports.

* Understand and follow aseptic behavior, good laboratory and manufacturing practices, and documentation.

* Author/update laboratory procedures, protocols, and help in EM data trend reports.

* Support cleanroom qualification, gowning qualification, aseptic process qualification, and personnel monitoring for manufacturing activities.

* Initiate non conformances for OOS results and work with the team to find a root cause and corrective actions.

* Perform QC lab support activities like lab set up, housekeeping, instrumentation maintenance, and coordinate instrument calibration.

Required:

* B.S. degree in Biology/ or other life science related degree with 0-3 years of relevant industry experience in a quality control role. While working towards a completed B.S. degree, consideration will be given to associate degree in Biology or related life sciences with 2-5 years direct industry experience.

* Excellent knowledge of Aseptic technique and common microbiological testing

* Knowledge of relevant, compliance and guidance documents

* Must be able to gown into cleanrooms in support of testing and manufacturing activities

* Good documentation (ALCOA +) and data organization

* Ability to work weekends is required; while most of the schedule will be during a standard work week, there will be regular weekend work.Interpersonal skills and ability to contribute to the success of a team

Preferred:

* Proven history of working in a fast-paced team environment, time management, and meet deadlines.

* Team player with the ability and willingness to support other colleagues in the Quality Control department. This support may include future cross training with analytical assays as needed

* Models our Core Values: Bold, Caring, and Results-Driven - consistently exemplifies the culture we strive to create, operates with transparency, and earns trust.

Job Title : QC Microbiology, Analyst

Location : Westborough, MA 01581

Duration : 06 Months

Job Description :

• The primary purpose of the Analyst I position is to Support Quality Control Microbiological testing of drug substances, raw materials and process intermediates in support of clinical development and commercial programs under cGMP and GLP guidelines, address excursions and conduct investigations.
• Perform QC testing of samples for bioburden, microbial identification, growth promotion, and Endotoxin analysis.
• Support cleanroom qualification, gowning qualification, aseptic process qualification, and personnel monitoring for manufacturing activities.
• Experience in Environmental Monitoring and Pharma experience required