QC Environmental Analyst in Warren, NJ at Apex Life Sciences

Date Posted: 2/28/2018

Job Snapshot

Job Description

QC Environmental Control Analyst 

QC Environmental Control Analyst works both independently and with the team to collects, 
analyzes and trends environmental monitoring results for the controlled non-aseptic area, aseptic 
area, compressed gases, and aseptic personnel. Trend results within a lab environmental, reviews 
documents, trains personnel, writes procedures, investigations and CAPA’s 

Required Competencies:

 Advanced ability to deal appropriately with regulatory agencies. 
 Advanced knowledge of current Good Manufacturing Procedures (cGMP), USP, EU and other 
global regulatory requirements. 
 Basic knowledge of OSHA and DEA. 
 Advanced written and communication skills. 
 Advanced communication skills with peers, department management and cross-functional 
 Advanced basic MS Word, Outlook, Excel, MS PowerPoint, Visio. 
 Ability to gown and maintain sterile work environment. 
 Ability to work cooperatively as a team leader, an individual contributor and as a team member. 
 Advanced ability to Interpret and write general business documents. 
 Advanced ability to Interpret and write technical documents. 
 Advanced Problem solving skills. 
 Ability to follow direction well, work cooperatively as an individual contributor and as a team 
 Ability to gown and maintain a sterile work environment. 
 Intermediate proficiency in Microsoft Word, Outlook, and Excel. 
 Intermediate knowledge of cGMP, OSHA, DEA, USP, and EP. 
 Ability to pass an initial full physical with annual monitoring. 

Duties and Responsibilities 
Collect environmental monitoring samples: 
 Collect viable and non-viable samples within controlled environments 
 Collect personnel glove and gown samples 
Participates in aseptic process qualifications: 
 Aseptic gowning 
 Media fills 
Documents, Tracks, and Trends test results: 
 Record daily data results 
 Performs initial review of critical cGMP documents supporting batch release and controlled area 
 Provides technical input for revisions to controlled documents such as Standard Operating 
Procedures and Controlled Forms. 
 Prepares spreadsheets of data 
 Trends site specific data 

Assist in the creation, maintenance, and delivery of controlled and aseptic area training 
Perform duties of a qualified trainer and assist department Management with employee training 
 Perform qualifications. 

Lab Duties: 
Prepare microbiological testing media and perform quality control testing of media used in the microbiological testing of bulk pharmaceutical raw materials, In Process and Finished product. 
Perform Media Fill Growth Promotion. 
Perform microbial isolation techniques and perform Gram stain identifications. 
 Initiate and perform Deviation Investigations/CAPA’s associated with Microbiological testing. 
Performs other duties as assigned. 

Education and Experience: 
Bachelor’ degree preferred, preferably in science or related field. 
environment with cGMP requirements. 
An equivalent combination of experience/education is acceptable. 

FOR IMMEDIATE CONSIDERATION please send your resume to grucci@apexlifesciences.com and add 'QC Environmental' in the subject line of your application e-mail. Please call 732-636-1497 to discuss advancement role.

EEO Employer

Apex is an Equal Employment Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by law. Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact our Employee Services Department at employeeservices@apexsystemsinc.com or 844-463-6178.