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Quality Assurance Specialist 032

Company Name:
MedTeam Staffing
This is a temporary job opportunity
Position: Quality Assurance Specialist 032
Location: Cheshire CT
Projected duration: 6 months
Job Code: 032
Quality Assurance Specialist IV
Position Summary
The QA Specialist IV will assist in daily activities for the ongoing development and operations of the GMP and GLP Archive with Quality Assurance. In support of Document Control, the candidate will take the lead in carrying out the operational requirements that result from policies, procedures, regulations, and guidances governing the management of records that exist in print and electronic form. This role will help manage record retention schedules, outreach to other internal/external archival support staff, and the acquisition of GMP/GLP Archive records.
Record control will be maintained at many levels, such as original hardcopies, electronic files, and physical security. The QA Specialist IV will coordinate documents such as laboratory notebooks, binders, procedures, photographs, computer printouts, protocols, technical reports, resumes, audits, facility records, validation documents, and certificates of analysis.
The QA Specialist IV will contribute to the completion of milestones associated with specific projects and supports quality systems related to document reviews, training, change control, deviations, corrective actions/preventative actions, and investigations.
Expedient retrieval of organized and complete records for internal requests, agency requests, and regulatory inspections is a key element to this position. Equally important is the ability to review documents for compliance to regulations, guidances, and internal procedures/policies. This position will provide the incumbent the unique opportunity to lead in various areas of GMP/GLP Quality Systems.
Principal Responsibilities
Ensure research, laboratory operations, and manufacturing comply with GMPs/GLPs, industry best practices and regulations including: 21 CFR Part 210, 21 CFR Part 211, 21 CFR Part 58, ICH, and OECD Guidances.
Perform document reviews for procedures, methods, specifications, stability protocols, method/equipment/computer qualification/validation documents, technical reports, final reports, etc. Complete data audits.
Create and maintain accessible, retrievable GMP/GLP archives and databases. Organize and catalogue archival records and develop classification systems to facilitate access to archival materials in an expedient manner.
Prepare document descriptions to preserve records. Scanned documents will be stored per the proper computer format and location. Details will be entered, transcribed, stored, and maintained.
Conduct searches and assistance for users needing or initiating archival materials. Supply guidance and advice to management on technical, system, or process-related topics. Information will be delivered by telephone, in written form, e-mail, or in person. Provide copies (either paper or electronic) upon request.
Communicate with external archiving facilities (long-term storage) and research organizations to coordinate incoming and outgoing shipments. Ensure that items are properly packed, catalogued, tracked, scanned, and acquired/discarded to provide a chain of custody.
Process documentation into and out of the GMP/GLP Archive. Maintain and update the inventory/database of documentation.
Implements procedures governing the management of records and quality systems. Offers feedback periodically to determine needs, assess risk mitigation, and ensure compliance to company procedures and regulations.
Trends and analyzes quality system data to measure key performance indicators, identifies areas for continuous process improvements and risk mitigation, compiles and presents analyses at Quarterly Management Review meetings, and proposes appropriate CAPA.
Acts as the lead for the preparation of adherence to the record retention schedule and manages methods for disseminating information.
Works with IT support staff to process and preserve electronic records.
Proposes and participates in continuous improvements.
Provides support for internal audits for GMP/GLP compliance.
Qualifications
Minimum of 7 years GMP related experience in biopharmaceutical / pharmaceutical or related industry.
Experience in developing, implementing, and evaluating archives or records management processes and systems. This includes cataloging, filing, and retrieving of records.
Experience with GMP/GLP global regulatory requirements.
Experience with electronic systems (e.g. FirstDocs and TrackWise) and databases. Capable of moving, copying and recovering large numbers of files and folders in a Windows environment.
Knowledge of the creation and management of records retention schedules
Knowledge of archival metadata and metadata management
Ability to work in a fast-paced environment
Performs a variety of tasks
Education
BS/BA degree in Chemistry, Biology or related field
Competencies
Convey information effectively through excellent written and verbal communication skills.
Ability to exercise judgment with defined procedures and practices to determine appropriate action.
Ability to prioritize daily activities in order to meet internal and external customer needs for established timelines in a fast-paced environment.
Ability to monitor and report on assigned tasks, goals, and objectives.
Identify problems and review related information to develop options and implement solutions.
Ability to arrange items or actions in a certain order or pattern according to a specific rule or set of rules (e.g., patterns of numbers, letters, words, pictures, operations).
Understand the challenges and opportunities in developing processes for effective capture, preservation, and management of paper and electronic records.
Demonstrate high quality work that is detail oriented.
Focus on customer service.

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