Manager, Data Reviewer
2 weeks ago
GENERAL DESCRIPTION
The Quality Data Reviewer Manager position, under general direction, will be responsible for overseeing the data review of routine and non-routine quantitative and qualitative analysis of samples submitted to the Quality Control (QC) Laboratory, to ensure compliance with internal procedures and client test methods/protocols/specifications. The Quality Data Reviewer Manager is responsible to ensure activities are reviewed in an efficient and cGMP compliant manner. The Quality Data Reviewer Manager is expected to take initiative, be proactive and lead the data review team. The Quality Data Review Manager will support the Quality Control Laboratory and Quality Assurance (QA) Operation by reviewing/approving analytical data, investigations, deviations, protocols, and analytical test methods to ensure compliance with internal procedures and the quality system.
ESSENTIAL JOB DUTIES
- Workflow management with multiple reviewers by overseeing the day-to-day operation within the data review department.
- Team leadership of the data review team.
- Mentor and train entry level personnel.
- Review and approve of analytical data, laboratory investigations and deviations.
- Review and approve change controls of analytical methods, protocols, and reports.
- Promotes ALCOA+ in documentation, cGMP culture and adheres to the quality system.
- Review time of use logs on cGMP instrumentation and other analytical equipment.
- Review audit trails on computer systems used to acquire and process data from instrumentation (e.g., Empower)
- Ensures compliance of testing with laboratory procedures, test methods and protocols.
- Review/Approve/Reject Drug Product Specifications
- Generate, review, and approve certificate of analyses for release testing or stability testing as applicable
- Work with laboratory personnel to correct any errors and omissions in GMP documentation.
- Engage in continuous improvement activities and adhere to department goals/metrics.
- Participating in audits, cycle audits or client audits as needed.
- Reply to client's questions concerning analytical laboratory data.
- Generate Metrics - (errors by analyst, review category, turnaround times) as needed
- Good Verbal and written communication skills across multiple departments.
- Other duties can be assigned as need it per Director of Quality.
REQUIRED SKILLS/ABILITIES
- Ability to pay attention to detail, focus and multitask on data review.
- Ability to use a computer to accurately to analyze data and generate reports as needed.
- Strong prioritization, organizational skills and detailed oriented.
- Knowledge of various analytical equipment and techniques (e.g liquid and gas chromatography, pH, dissolution).
- Communicate with others clearly and concisely.
- Ability to work in a fast-paced environment
- Proficient in Microsoft Word and Excel.
- Fluency in written English
- Proofreading skills
WORK EXPERIENCE AND REQUIREMENTS
- 5+ years of related experience in pharmaceutical analysis and cGMP regulated industry. Strong analytical background with good documentation practices. Strong Organization Skills.
- Analytical Laboratory experience Required (5+ years)
EDUCATION REQUIREMENTS
- B.S. degree in chemistry or closely related discipline
- M.S. in chemistry or closely related discipline may substitute for work experience
PHYSICAL DEMANDS
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.
While performing the duties of this job, the employee is regularly required to talk and hear. The employee will be performing work in multiple buildings on the campus; The frequently is required to stand and walk.; use hands to finger, handle or feel; and reach with hands and arms. The employee will be required to focus on reading/evaluating documents and expected to have great attention to detail.
WORK ENVIRONMENT
Office Environment
-
Data Warehouse Manager
1 week ago
Clearwater, United States Qwalifize LLC Full timeJob DescriptionJob DescriptionType:Contract to hire Full Time or Part Time:Full timePay Rate:TBDLocation:Clearwater, FL 33756.Language Requirements: Write, read, and speak English fluently Language Preferences: Also Spanish Job Overview: We are looking for a full time Data Warehouse Manger that does deep expertise in data analysis, data modeling, data...
-
Data entry Clerk
1 week ago
Clearwater, United States 5 Star Staffing Solutions Full timeJob DescriptionJob DescriptionWe are seeking to add a Data Entry Clerk to our team! You will be responsible for accurate data entry, file maintenance, and record keeping.Responsibilities:Enter variety of data using current technologyPrepare and sort documents for data entryCreate and maintain logs for tracking purposesReview and enter data updates in the...
-
Data Architect
7 days ago
Clearwater, United States CareerBuilder Full timeType: Temporary Full Time or Part Time: Full time Pay Rate: TBD Location: Clearwater, FL 33756 Language Requirements: Write, read and speak English fluently Overview: We are seeking Data Architect professionals to work onsite in Clearwater, FL . Typically, assignments range from three (3) weeks to six (6) months. Assignments will not exceed eighteen (18)...
-
Data Architect
1 week ago
Clearwater, United States Qwalifize LLC Full timeJob DescriptionJob DescriptionType: TemporaryFull Time or Part Time:Full timePay Rate: TBDLocation:Clearwater, FL 33756Language Requirements:Write, read and speak English fluentlyOverview:We are seeking Data Architect professionals to work onsite in Clearwater, FL . Typically, assignments range from three (3) weeks to six (6) months. Assignments will not...
-
District Manager
Found in: Talent US C2 - 1 week ago
Clearwater, United States Cellairis Full timeCore Competencies: Leader by nature Persuasive personality Skilled at strategic planning, execution, and analysis Self-Motivated and a Motivator Persistent in nature and results-oriented Self-Disciplined Tech-Savvy Required Attitude/Personality: Drive and Urgency: Has tremendous energy and initiative to generate sales and can...
-
IT Data Engineer III
1 week ago
Clearwater, United States CareerBuilder Full timeThe successful candidate will demonstrate: Expertise in DW concepts, think Bill Inmon & Ralph Kimball Strong analytical abilities and creative problem solving Work with data stakeholders (technical as well as end users) to understand business requirements and implement database solutions for diverse problems. We do not leverage a Business Analyst as a go...
-
Program Manager
7 days ago
Clearwater, United States Smiths Interconnect Inc. Full timeJob DescriptionJob DescriptionWe are seeking a Manufacturing Program Manager to play an integral role within several programs, analyzing, monitoring and reporting on programs from inception through to completion and review. The Program Manager will be responsible for managing multiple, diverse, simultaneous design & development programs of varying...
-
Manager of Managed Care
1 week ago
Clearwater, United States CareerBuilder Full timeThe Manager of Managed Care: Monitor state and federal contract requirements and work with internal and external business partners to achieve 100% compliance. Collaborate with leadership, identify appropriate contracting and re-contracting opportunities and initiate discussions with key constituents. Create and maintain high level contacts with existing and...
-
Corporate Insurance Risk Manager
1 week ago
Clearwater, United States MarineMax Full timeOVERVIEW: The Corporate Insurance Risk Manager is responsible for supporting the company's risk management team with the daily administration and annual renewal of the insurance programs for designated entities of the Company; assisting business unit staff with insurance issues relating to contracts and insurance coverages; and working with key internal and...
-
Corporate Insurance Risk Manager
3 days ago
Clearwater, United States CareerBuilder Full timeOVERVIEW: The Corporate Insurance Risk Manager is responsible for supporting the company's risk management team with the daily administration and annual renewal of the insurance programs for designated entities of the Company; assisting business unit staff with insurance issues relating to contracts and insurance coverages; and working with key internal and...
-
Sales Manager
7 days ago
Clearwater, United States Faster Way to Fat Loss Full timePosition Summary Join our dynamic team as a Sales Manager and be a key player in driving the success of one of the fastest-growing online fitness and nutrition brands in the country. We are seeking a motivated and results-oriented individual to lead our sales team. In this role, you will be responsible for developing and implementing sales strategies to...
-
Sales Manager
7 days ago
Clearwater, United States EmergencyMD Full timePosition Summary: Join our dynamic team as a Sales Manager and be a key player in driving the success of one of the fastest-growing online fitness and nutrition brands in the country. We are seeking a motivated and results-oriented individual to lead our sales team. In this role, you will be responsible for developing and implementing sales strategies to...
-
Clearwater, United States The Sports Facilities Companies Full timeJob DescriptionJob DescriptionACCOUNTING MANAGERThe Sports Facilities CompaniesLOCATION: Clearwater, FL DEPARTMENT: FINANCE REPORTS TO: CHIEF FINANCE OFFICERSTATUS: FULL-TIME (EXEMPT)ABOUT THE COMPANY:The Sports Facilities Companies (SFC) are the Nation's leading resources for the management and development of sports, recreation, wellness, and events...
-
Asset Management Technical Coordinator
Found in: Talent US 2 C2 - 2 weeks ago
Clearwater, United States Pinellas County FL Full timeAsset Management Technical Coordinator Classification Title: Project Coordinator, Technical, E23 Location: US Highway 19 N., Building 1, Clearwater, FL Schedule: Monday – Friday, 8:00 AM – 5:00 PM; some remote work available Public Works is dedicated to improving safety, protecting the environment and enhancing the quality of life in...
-
Tax Manager
9 hours ago
Clearwater, United States Creative Financial Staffing Full timeTax Manager Why take a Tax Manager role with this company? Team oriented company headquartered in Clearwater, FL Flexible hours and strong work/life balance Manager is very easy going and not a micromanager Company has a fun atmosphere doing special events throughout the year like a haunted house and cookouts on 4th of July Tax Manager will be reporting...
-
Clearwater, United States Princess K Investments Full timeJob DescriptionJob DescriptionJob SummaryResponsible for all front office functions and staff. Areas of responsibility include Switchboard Operations, Guest Services and Front Desk. As a department head, directs and works with managers and associates to successfully execute all front office operations, including guest arrival and departure procedures....
-
Project Manager
5 days ago
Clearwater, United States Georgia IT Inc Full timePosition Project Manager Location Clearwater FL Duration 6 months Rate - DOE Job description Project Manager with MES and Data Migration Experience The project manager needs to physically present at site from Monday to Friday to work along with site team. The project manager should have a data migration experience on MES and ERP projects.
-
Accounting Manager
5 days ago
Clearwater, United States Lhh Full timeOur client is looking to hiring a rockstar Accounting Manager. The ideal candidate will assist in full cycle accounting and statutory reporting. Responsibilities Review direct reoports work including journal entries, reconciliations, unclaimed propery templates, fixed assets template, etc. Prepare monthly journal entries which includes recording tax...
-
Clearwater, United States Experis Full timeJob Title: Engineering Support Specialist Duration: 6+ Months Contract Location: Clearwater FL KEY RESPONSIBILITIES • Supporting programs with coordination and scheduling of customer meetings, design reviews, and data deliveries as needed by the program • Working with and supporting Project Engineers to help maintain schedules • Working with and...
-
City Service Moving Product Manager
4 days ago
Clearwater, United States PODS Enterprises LLC Full timeFind a career that MOVES you! PODS revolutionized the moving and storage industry 25 years ago. Our innovative approach of providing portable storage containers makes moving more efficient, convenient, and less stressful. Were not only pioneers of the industry, were the leader, too. Under the direction of PODS innovative leadership team, the company doubled...