Job Title: QC Microbiology Analyst
Duration: 12 Months
Location: Hopewell, NJ 08534
Pay rate starts from $45/hr. (Negotiable)

Duties:    
Perform QC Microbiology laboratory activities to support GMP manufacturing, testing and release of materials, intermediates, and finished products under FDA/EU regulations, applicable International Regulations, client processes and procedures. Support facility qualification activities for microbiological testing and environmental monitoring.

Essential Functions of the job:

• Perform QC Microbiology laboratory testing including bioburden, endotoxin, sterility, and microbial ID testing to ensure timely generation and reporting of test results (for In Process, Drug Substance, Drug Product, and Stability samples) in support of manufacturing operations.
• Support routine QC operations, including but not limited to: instrument qualification and maintenance, SOP generation and revision, specification update, record keeping and archival, etc.
• Manage inventory of reagents and supplies for the laboratory.
• Conduct laboratory investigations, including OOS, Out of Trend, deviations, and invalid assays.
• Implement corrective actions and preventive actions (CAPAs).
• Participate in facility qualification activities for microbiological testing and environmental monitoring.
• Perform environmental monitoring of cleanroom suites and laboratory areas as required.
• Required to gown into cleanrooms with different classifications and able to stand and move around for extended periods of time.
• Participate in method transfer and method validation activities, including protocol preparation, protocol execution, and report preparation.
• Undertake any other duties as required.

Education:    
Bachelor’s Degree or above in Microbiology, Biology, or Biotechnology related scientific discipline. 

Skills:    
Core Competencies, Knowledge, and Skill Requirements:

• Minimum of 2 years of working experience in an FDA-regulated biotechnology or pharmaceutical company.
• 5+ years of experience preferred with no higher education.
• Working knowledge and experience with microbiological testing methods such as endotoxin, bioburden, sterility testing, microbial identification, PCR, biological indicators, environmental monitoring, etc.
• Familiar with USP/EP and cGMP/EU GMP regulations.
• Familiar with instrument and equipment validation.
• Impressive, demonstrable track record and skills/experience gained within a similar position(s), at a similar level.
• Credible and confident communicator (written and verbal) at all levels.
• Strong analytical and problem-solving ability.
• Hands-on approach, with a ‘can do’ attitude.
• Ability to prioritize, demonstrating good time management skills.
• Excellent attention to detail, with the ability to work accurately in a busy and demanding environment.
• Self-motivated, with the ability to work proactively using own initiative.
• Committed to learning and development.

Computer Skills:
Strong PC literacy required; MS Office skills (Outlook, Word, Excel, PowerPoint).

Travel:

• Must be willing to travel approximately 10%.
• Ability to work on a computer for extended periods of time.

Below is the brief introduction of SPECTRAFORCE, the benefits we offer and the disclaimers:
Established in 2004, SPECTRAFORCE is one of the largest and fastest-growing diversity-owned staffing firms in the US. The growth of our company is a direct result of our global client service delivery model that is powered by our state-of-the-art A.I. proprietary talent acquisition platform, robust ISO 9001:2015/ISO 27001 certified processes, and strong and passionate client engaged teams.
We have built our business by providing talent and project-based solutions, including Contingent, Permanent, and Statement of Work (SOW) services to over 130 clients in the US, Canada, Puerto Rico, Costa Rica, and India. Key industries that we service include Technology, Financial Services, Life Sciences, Healthcare, Telecom, Retail, Utilities and Transportation.
SPECTRAFORCE is built on a concept of “human connection,” defined by our branding attitude of NEWJOBPHORIA®, which is the excitement of bringing joy and freedom to the work lifestyle so our people (and clients) can reach their highest potential.  Our entire workflow and teams are trained to cultivate the joy of NEWJOBPHORIA® with candidates and employees throughout their engagement with SPECTRAFORCE. http://www.spectraforce.com
 
Benefits: SPECTRAFORCE offers ACA compliant health benefits as well as dental, vision, accident, and hospital indemnity insurances. Additional benefits SPECTRAFORCE offers to the eligible employees include commuter benefits, 401K plan with matching and a referral bonus program. SPECTRAFORCE offers unpaid leave as well as paid sick leave when required by law.
 
Equal Opportunity Employer: SPECTRAFORCE is an equal opportunity employer and does not discriminate against any employee or applicant for employment because of race, religion, color, sex, national origin, age, sexual orientation, gender identity, genetic information, disability or veteran status, or any other category protected by applicable federal, state, or local laws. Please contact Human Resources at nahr@spectraforce.com if you require reasonable accommodation.