This position will be responsible for workflow management and review of change control documentation and documents in Document management system, issuance of production work/support orders, tracking pending tasks in electronic quality management system and coordinate/follow up for completion.
location: Los Angeles, California
job type: Contract
salary: $37 - 43 per hour
work hours: 9 to 5
education: Bachelors
responsibilities:
- Responsible for review and workflow management of change control records in electronic Quality Management System (Veeva)
- Responsible for review of change control and associated requirements documentation for accuracy, completeness, compliance with cGMPs and applicable standards
- Will generate reports on a scheduled basis for the status and tracking of open change control records
- Responsible for follow-up on status/open items related to change control
- Responsible for issuance of tag-outs for equipment/facilities as required by change control
- Generate reports and data for Key Performance Indicator reporting
- Coordinate and follow up to ensure timely completion of change control requirements for shutdown projects including authorization of area back to production and product release
- Responsible for processing and maintenance of documents in Document Management System managing workflows of review, approval, issuance, and effective.
- Assist as needed for projects related to document management systems and change control
- Familiar with Microsoft Excel, eQMS, Access to utilize for tracking, trending, and data entry.
- Communicate effectively with multiple departments in order to provide customer service.
qualifications:
- Bachelor's degree and a minimum of 2 years of related experience; or an advanced degree without experience; or equivalent work experience. Related cGMP industry experience is desirable
- Experience working with eQMS highly desirable
- Ability to keep neat, accurate and complete records and logs.
- Must be proactive, results oriented, with a strong attention to detail.
- Self-starter with good work ethic and ability to work independently with minimum supervision and use good judgment, or as a contributing member of a team.
- Ability to manage multiple projects simultaneously, meet deadlines, and handle an ever changing, fast paced critical work environment.
- Strong organizational, analytical, troubleshooting and problem-solving skills.
- Ability to analyze details and perform structured decision-making on a daily basis.
- Excellent verbal and written communication. Must be able to read, write, and speak English.
- Strong interpersonal skills with ability to interact with all levels of personnel in a professional manner.
- Good computer skills with basic knowledge of Microsoft programs, particularly Outlook, Word, Excel, Access, etc.
skills: Change Control Management, Quality Management Systems (QMS)
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.
At Randstad, we welcome people of all abilities and want to ensure that our hiring and interview process meets the needs of all applicants. If you require a reasonable accommodation to make your application or interview experience a great one, please contact HRsupport@randstadusa.com.
Pay offered to a successful candidate will be based on several factors including the candidate's education, work experience, work location, specific job duties, certifications, etc. In addition, Randstad offers a comprehensive benefits package, including: medical, prescription, dental, vision, AD&D, and life insurance offerings, short-term disability, and a 401K plan (all benefits are based on eligibility).
This posting is open for thirty (30) days.
Qualified applicants in San Francisco with criminal histories will be considered for employment in accordance with the San Francisco Fair Chance Ordinance.
Qualified applicants with arrest or conviction records will be considered for employment in accordance with the Los Angeles County Fair Chance Ordinance for Employers and the California Fair Chance Act.
We will consider for employment all qualified Applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance.
