Analyst II - Stability

Job#: 2033009

Job Description:

Job Summary
The Stability Analyst II position under general supervision, performs work that is varied and that may be somewhat difficult in character, but usually involves limited responsibility. Some evaluation, originality or ingenuity is required. Follows established protocols and work plans. May be assisted by laboratory technicians/assistants. Comply with divisional and site Environmental Health and Safety requirements.
Specific Duties, Activities, and Responsibilities  (% of time)
1. Execute laboratory work plan / schedule developed with input from supervisor or senior team member 70%
2. May draft technical documents such as methods, certificates of analysis or investigations 10%
3. Performs parallel review of laboratory documentation and may become qualified to perform technical review of documents for accuracy, thoroughness and regulatory compliance 5%
4. Trains others on laboratory techniques 5%
5. Assists in the execution of efficiency improvement project with guidance 5%
6. All other duties as assigned 5%
Job Requirements
Education and Experience:
• Master’s degree and 0-2 years related experience;
• Bachelor’s degree and 3-5 years related experience; or
• Associate’s degree and >6 years related experience or equivalent education, experience, and training

Knowledge, Skills and Abilities:
• All employees must receive training on the fundamental principles of Good Manufacturing Practices (GMP), Good Documentation Practices (GDP), Data Integrity, and employee conduct as a condition for performing GxP activities.
• All employees performing GxP activites must be trained, at least annually, on the requirements established for GxP Documentation and Data Integrity.
• Maintain high quality laboratory documentation in accordance with applicable regulatory guidance and Site SOPs
• Ability to learn and retain technical information
• Proactively address work issues at both an individual level and a team level
• Develop and execute procedures or methods of moderate complexity with high quality
• Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form
• Mathematical and scientific reasoning ability
• Basic understanding of instrument operations and troubleshooting skills in multiple techniques
• Ability to identify aberrant/out of spec data and limited interpretation of data expected.
Working Conditions and Environment:
• This position will be stationed in an office and laboratory environment involving work near moving/mechanical parts; working around various chemicals including biologics, active pharmaceuticals, beta-lactams and radioactive materials; and other conditions reasonably expected due to the nature of the work required
• Position may require domestic or international travel
• Flexibility required to work outside normal working hours of 8:00 a.m. – 5:00 p.m.

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

EEO Employer

Apex Systems is an equal opportunity employer. We do not discriminate or allow discrimination on the basis of race, color, religion, creed, sex (including pregnancy, childbirth, breastfeeding, or related medical conditions), age, sexual orientation, gender identity, national origin, ancestry, citizenship, genetic information, registered domestic partner status, marital status, disability, status as a crime victim, protected veteran status, political affiliation, union membership, 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 [email protected] or 844-463-6178.