QC Reviewer - Document Control - GMP - 160189
EXPECT MORE FROM YOUR CAREER
PPD is a leading global contract research organization. At PPD we are passionate, deliberate, and driven by purpose- to improve health.
PPD Laboratories offers the most comprehensive set of laboratory services available in the industry and continues to deliver innovative solutions to our clients through our collaborative approach, including PPD Laboratories FSP. PPD Laboratories FSP is a unique partnership that allows our clients to leverage the experience of our PPD staff, while allowing you, the employee, to gain direct experience working onsite at a pharmaceutical/ biopharmaceutical company, all while maintaining full-time benefits/advantages of being a part of PPD.
As a QC Reviewer, you will ensure the quality of laboratory data and reports, provide document coordination, and maintain GxP compliance.
Additional responsibilities for the role on site at a major biopharmaceutical company:
Processes/procedures, scanning, filing, indexing of GxP related documents and records and coordination of off-site records.
Processing Stability Studies and Sampling Plans within in tight timelines.
Analyzes Change Requests for completeness.
Communicates with customers to ensure changes are concise and complete.
Interacts with appropriate departments to establish priorities and deadlines for processing CRs, DCOs and documents.
Works on assignments that are moderately complex in nature where ability to recognize deviation from accepted practice is required.
Provides support with internal and regulatory audits/inspections as required.
Ensures the correct and timely implementation of Change Requests (CR), Document Change Orders (DCOs) and Documents.
Supports the distribution and maintenance of GXP documentation.
Provides clerical and administrative support related to documentation processes and systems.
Maintains documentation manuals to ensure accuracy and current information.
Scans, verifies and archives documentation and records.
Ensures the correct and timely input of database entries.
Performs general word processing tasks and support.
Checks format and conformance to document templates.
Verifies own work and provides support for internal and regulatory audits/inspections as required.
Provides additional support and assistance on tasks and projects as directed by management.
Participates as required in training on issues affecting own area of work. N
Notifies manager of compliance questions and issues.
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Education and Experience:
Bachelor's degree or equivalent and relevant formal academic / vocational qualification with preference to scientific field
Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 2+ years’) or equivalent combination of education, training, & experience.
MS Office experience required
Viva experience a plus
Knowledge, Skills, and Abilities:
Knowledge of SOPs and Federal Regulations to include GLP and GMP
Knowledge of chromatography and divisional SOPs
Knowledge of MS Office; Viva a plus
Verbal and written communication skills
Attention to detail
Ability to deal with multiple and changing priorities
Ability to provide clear and concise feedback and/or documentation of results
Ability to work in a collaborative team environment
PPD values the health and wellbeing of our employees. We support and encourage individuals to create a healthy and balanced environment where they can thrive. Below is listed the working environment/requirements for this role:
Able to communicate, receive, and understand information and ideas with diverse groups of people in a comprehensible and reasonable manner.
Able to work upright and stationary for typical working hours.
Ability to use and learn standard office equipment and technology with proficiency.
Able to perform successfully under pressure while prioritizing and handling multiple projects or activities.
"document coordinator" , "archive" , "data entry"
Organization - Labs
Primary Location - US-CA-Foster City-FSP Foster City CA