Yoh is hiring for a Quality Documentation Specialist for our Pharmaceutical client in Noblesville, Indiana. This is a great opportunity to join a growing facility.Summary of PositionSchedule: Monday - Friday 8:00 am - 5:00 pm Pay Rate: $34-$40/hrDuration: 6 month contract with possibility of conversion The (Contractor) Principal Quality Documentation Specialist position is responsible for coordination and management of the administration and execution of the Document Control systems. The position is responsible for document processing, maintenance of documents/records, issuance of logbooks, notebooks and protocols, and maintenance of various indices/logs. The position is responsible for ensuring compliance to applicable internal procedures, cGMPs, and regulatory requirements. Essential Functions
- Coordination and dissemination of daily assignments to the Document Control Team.
- Process various site documents using computer-based systems, including, but not limited to, Standard Operation Procedures (SOPs), Standard Certification Methods (SCMs), Standard Testing Methods (STMs), Specifications, and Batch Production Records.
- Catalog, scan, maintain, archive/file and retrieve various site documents/records, including, but not limited to, SOPs, Batch Records, Datasheets, Logbooks, Notebooks, Regulatory Documents, and Validation Protocols.
- Prepare and issue logbooks and notebooks for use across the site.
- Collaboration and coordination with other functions (e.g. Document Owners, Quality Systems Administrators, and Training), as necessary, in the processing of documents.
- Support Regulatory Affairs (US and Canada) by supplying current/historical documents and assist in gathering information for audit events.
- Ensure daily tasks are completed in a timely manner with strict attention to detail, and in accordance with applicable Standard Operating Procedures and cGMPs.
- Must maintain operational compliance with US and international regulatory agencies and guidelines (i.e. FDA, EU, HC, TGA, PIC/S, ISO, USP, NRC, cGMP, etc.).
- Lead training efforts for Document Control processes for new personnel to the department.
- Provide support (preparation, set-up, breakdown, and assist with the retrieval of requested documents) for FDA or other regulatory inspections and customer audits.
- Troubleshoot anomalies and formatting issues in Microsoft programs.
- Assist in Exception investigations, including root cause analysis and resolution with effective and timely corrective action.
- Perform document cross-reference searches using advanced search parameters.
- Ensure maintenance of the department, premises, and equipment.
. Requirements
- Associate degree preferred, High School Diploma or equivalent required. Work experience is considered in lieu of degree.
- 6 or more years of relevant work experience required.
- Experience with computer data entry required. Must be proficient with Microsoft Office, including Word, Excel, Access, Visio, Outlook, and Power Point.
- Willing to work occasional overtime and weekends as the business need dictates.
- Ability to work well both independently and in a team atmosphere.
- Demonstrated ability to closely adhere to all instructions, cGMP's, SOP's, policies and procedures required.
- Ability to accurately type 45 words per minute.
Estimated Min Rate: $34.00 Estimated Max Rate: $40.00#IND-SPGNote: Any pay ranges displayed are estimations. Actual pay is determined by an applicant's experience, technical expertise, and other qualifications as listed in the job description. All qualified applicants are welcome to apply.Yoh, a Day & Zimmermann company, is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.Visit to contact us if you are an individual with a disability and require accommodation in the application process.For California applicants, 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. All of the material job duties described in this posting are job duties for which a criminal history may have a direct, adverse, and negative relationship potentially resulting in the withdrawal of a conditional offer of employment.