Job Summary: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 and logs, tracking pending tasks in electronic quality management system and coordinate/follow up for completion and performing daily database operations, including data entry, report preparation, and distribution.
Essential Job Duties:- Responsible for the daily data entry and managing of change control documentation in the Access Change Request Database
- 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 of all open/closed change requests and issuance of documents.
- Responsible for follow-up on status/open requirements for change control
- Responsible for sending notification to other Grifols sites as required by 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
- 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 and Access to utilize for tracking, trending, and data entry.
- Communicate effectively with multiple departments in order to provide customer service.
Job Requirements:- 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 judjent, 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.
Occupational Demands : Work is performed in an office and a laboratory/manufacturing environment or warehouse. Exposure to biological fluids with potential exposure to infectious organisms. Exposure to occasional extreme cold below 32* in production areas. Exposure to electrical office and laboratory equipment. Personal protective equipment required such as protective eyewear, garments and gloves. Work is performed sitting or standing for 2-4 hours per day. Frequent hand movement of both hands with the ability to make fast, simple, movements of the fingers, hands, and wrists. Ability to make precise coordinated movements, of the fingers to grasp and manipulate objects. Light to moderate lifting and carrying objects with a maximum lift of 35lbs. Occasionally walks, bends and twists neck and waist, may reach above or below shoulder height. Frequent foot movements. Color perception/discrimination and near vision correctable in one eye to 20/30 and to 20/100 in the other eye. Able to communicate complex information and ideas so others will understand; with the ability to listen to and understand information and ideas presented through spoken and written words and sentences. Performs tasks by following a set of written or oral instructions/procedures.
*This job description is accurate at the date of publication. It is intended to provide information essential to understanding the scope and general nature of the work performed by job holders within this position. This job description is not intended to be an exhaustive list of qualifications, skills, duties, responsibilities or working conditions associated with the position. Other duties may be assigned and qualifications required may change over time.
The estimated pay scale for QA Coodintor ole based in California, is $79,318 - $99,147. Additionally, the position is eligible to participate in up to 5% of the company bonus pool. We offer a wide variety of benefits including, but not limited to: Medical, Dental, Vision, life insurance, PTO, paid holidays and up to 5% 401(K) match and tuition reimbursement. Final compensation packages will ultimately depend on education, experience, skillset, knowledge, where the role is performed, internal equity and market data. We are committed to offering our employees opportunities for professional growth and career progression. Grifols is a global healthcare organization with employees in 30 countries focused on patient health and providing impactful results. Since our humble beginnings in 1909, Grifols has been a family company that prides itself on its family-like culture. Our company has more than tripled over the last 10 years, and you can grow with us!
Third Party Agency and Recruiter Notice:Agencies that present a candidate to Grifols must have an active, nonexpired, Grifols Agency Master Services Agreement with the Grifols Talent Acquisition Department. Additionally, agencies may only submit candidates to positions that they have been engaged to work on by a Grifols Recruiter. All resumes must be sent to a Grifols Recruiter under these terms or they will be considered a Grifols candidate.
Location: NORTH AMERICA : USA : CA-Los Angeles:USVALLEY - Valley Bl Mfg Plant - LA, CALearn more about Grifols
