Quality Assurance Specialist, Training/Document Control
11388 Sorrento Valley Road San Diego, CA 92121 US
Pay Rate Range: $20-27/hr
This position will provide support to multiple functions in the area of Quality Systems. The activities will focus mainly on training and Quality records management and may involve any related Quality System activities.
ESSENTIAL FUNCTIONS AND RESPONSIBILITIES:
These may include, but are not limited to:
• Maintain/Administer/Support the Training Program:
o Preparation with the on-boarding of new employees and training files;
o Administer User account set-up for new hires;
o Maintain QA signature record file;
o Monitor Training In Box and provide internal customer support on the learning management electronic system;
o Administer training courses, curriculums and user groups in the learning management software (LMS);
o Maintain and monitor the Training Program;
o Run monthly training status reports and distribute to management
o Maintain training-related employee records (training syllabus, job description, new employees, promoted employees, terminated employees, etc.)
• Maintain/Support Quality records
o Lab notebooks: issuance; retrieval; reconciliation; scan; archive
o Quality Records: scan, file; retention; reconciliation and inventory of documents to be sent to offsite storage, and the destruction per Records Retention Schedule/Policy
o Oversee the upkeep of the Quality controlled document room
• Support as a back-up to the Controlled Document System
o Assist as a back-up to the Controlled Document System in electronic document software;
o Assist with processing and issuing with new/revised/obsolete documents;
o Provide internal customer support on electronic document management system;
o Scan, file, maintain and archive of controlled documents.
ADDITIONAL FUNCTIONS AND RESPONSIBILITIES:
• Develop, revise, and implement departmental policies and procedures;
• Perform Quality Assurance activities to support programs as assigned;
• Adhere to Company’s core mission and values;
• Other duties as assigned
EDUCATION, EXPERIENCE, KNOWLEDGE, SKILLS AND ABILITIES:
• A minimum of a Bachelors’ degree is preferred with at least 2 years’ Quality experience in pharmaceutical/biotechnology/medicinal products company environment (an equivalent combination of experience and education may be considered).
• Excellent problem-solving skills, analytical thinking, and visionary skills
• Excellent command of the English language
• Effective verbal and written communication skills, and ability to effectively interact with employees in a team-based environment
• Ability to learn quickly
• The ability to obtain a thorough knowledge of and to operate to the company’s operations, policies, and procedures in a short period of time.
• Ability to prioritize workload, to meet deadlines and to maintain high level of quality and accuracy
• Ability to take initiative, be resourceful and have attention to detail
• Must demonstrate effective decision-making skills and have the ability to respond to high-pressure situations
• Must possess a thoroughly professional and positive image at all times and a solid work ethic
• Good understanding of confidentiality of data which requires extreme sensitivity and discretion
TECHNICAL KNOWLEDGE REQUIRED:
Equipment: PC, scanners, facsimile machine, voice mail and e-mail systems, and common office machines, or ability to be trained. Knowledge of other equipment required: N/A
Software Knowledge: Windows, MS Office (Outlook, Word, Excel). Knowledge of other software required: N/A
INTERNAL AND EXTERNAL RELATIONSHIPS:
• Collaborate with internal and external customers and vendors as needed.
EFFORT REQUIRED/ENVIRONMENTAL CONDITIONS:
Physical Activities: On a continuous basis, sit at desk for a long period of time; intermittently answer telephone and write or use a keyboard to communicate through written means. Some walking and lifting up to 20 lbs. may be required. The noise level in the work environment is usually low to moderate. The physical demands described above are representative of those that must be met by an employee to successfully perform the essential functions and responsibilities of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions and responsibilities.
Laboratory Activities, if applicable: Biology and chemical laboratory environments experience needed. Environmental health and safety requirements also apply.