Sr. Operations Analyst in Social Circle, GA at Apex Life Sciences

Date Posted: 2/28/2018

Job Snapshot

Job Description


Drive maintenance compliance deliverables to ensure successful commercial operations, including: 

• Lead CAPA investigations to adequately identify root cause and implement appropriate corrective and preventative actions to prevent reoccurrence by: 
• Lead problem solving and root-cause analysis sessions 
• Interact with Manufacturing, Quality, Engineering and Tech Service units 
• Manage complex investigations using DMAIC tools 
• Ensure effective implementation of corrective and preventive actions 
• Lead investigations to resolve Out Of Tolerance instrument and equipment calibrations 
• Author and revise GMP documents, SOPs and engineering documents (e.g. PNIDs, Job Plans, Calibrations Procedures, ICLs, ICAs, Maintenance Assessments, Equipment Lifecycle, etc.) 

• Train staff in general compliance calibration and maintenance procedures 

• Collaborate in the mitigation of any environmental, Health, and Safety (EHS) needs and risks 

• Identify and implement improvement initiatives to improve calibration, equipment reliability, and/or maintenance process robustness. This may require leading and implementing change controls 

• Demonstrate continuous improvement with respect to increasing job knowledge and proficiency related to the biopharmaceutical industry, as well as technical understanding/problem solving capability 

• Stay current with biopharmaceutical industry best practices and technologies 

• Responsible for organizing data and preparing appropriate documentation, including presentation materials for assigned projects. 
• Gather and analyze empirical data, organize, maintain and present metrics and key performance indicators. 

• Strong problem solving and analytical skills are required. 
• Possess knowledge of core manufacturing principles and support systems 
• Must have excellent organizational, verbal and written communication skills; able to efficiently communicate with cross functional teams and management on recommended course of action, with minimal assistance. 
• Must have good interpersonal skills and be able to work effectively and efficiently in a team-based environment. 
• Self-driven individual that requires minimal supervision 
• Must have proficient computer skills and be experienced using MS Office software (Word, Excel and PowerPoint). 
• Working Flexible or alternate shifts may be required based on business needs. 

Education and/or Experience: 
• Bachelor of Science or Technical degree required 
• 0-4 years work experience 
• Professional (GMP industry) experience ideal but not required Working Environment: 
• May occasionally work in a clean-room environment and wear special garments (requires removal of make-up and jewelry) 
• May occasionally wear personal protective equipment (e.g. hard hats, safety shoes, safety glasses, ear plugs) due to safety requirements in specific areas. Company provides PPE 
• May be required to work weekends, evenings, and off-hours, extended periods of time

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 or 844-463-6178.


  1. Research Analyst Jobs
  2. Operations Analyst Jobs