Quality Control Scheduling Analyst Jobs

Experience: 1-3+ years of relevant work experience or equivalent combination of education and training

Skills: Proficient in Microsoft Office products, including advanced data functions in Excel.

Excellent analytical skills; Ability to collect and analyze data and present findings.

Strong organizational skills and attention to detail.

Strong verbal, written and interpersonal skills.

Charting for scorecard and governance packages.

In depth knowledge of anti-money laundering typologies, regulations, and guidance (BSA, KYC, etc.)

Superior oral and written communication/feedback skills

Proactive in partnering and communicating with Compliance/LOB partners.

Bachelors or advanced degree in business administration, criminal justice, intelligence studies or other related field of study

Participate in validation and technical transfer of analytical methods commensurate with experience

BA or B.S. degree in a science discipline required, or comparable experience

Prior experience related to method development/validation

Knowledge of pharmaceutical cGMP (US and EU) is preferred

Must have excellent verbal, written, interpersonal, and organizational and communication skills

Conduct routine and non-routine analytical, biochemical, and/or biological analysis such as, in-process materials, raw materials, finished goods, or stability samples

Knowledge of calibration and operation of HPLC system with empower software.

Hands on experience in handling equipment like HPLC, Dionex, GC, UV Visible Spectrophotometer.

Write and review Standard Operating Procedures for assays and qualifications associated with timelines.

Knowledge on Analytical Method Validation.

BS, Life Science with minimum 2+ years of experience in HPLC

Good communication and writing skills.

Strong knowledge and understanding of Managed Healthcare.

Ability to demonstrate initiative and discipline in time management and assignment completion

Bachelor’s degree in Finance or Accounting or equivalent experience.

Include minimum education, technical training, and/or experience preferred to perform the job.

Excellent communication skills, written and verbal.

Must display excellent interpersonal skills

Advanced Microsoft Office and SAP user experience preferred. Knowledge of LIMS and Trackwise preferred.

Experience in the manufacture of pharmaceuticals with knowledge of water systems, clean rooms, and aseptic filling and process validation.

We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees.

Responsible for microbiology lab investigations. Extensive knowledge of Global TrackWise System and lab procedures, processes and methods.

Investigates all out-of-limit conditions and with the direct support from the QC Lab Manager implement a corrective action.

Prepares trend and metric laboratory reports in conjunction with the Microbiology Manager.

FDA regulated industry (food, pharmaceutical or medical device) experience is required.

Minimum of 3 years relevant experience required.

Strong work ethic and organizational skills.

MAIN JOB RESPONSIBILITIES / COMPETENCIES

Pay range is $65k to $85k - Final compensation will depend on experience.

High School diploma or GED.

Adheres to all applicable procedures, cGMP’s, company policies, and all other quality or regulatory requirements (OSHA , FDA/CVM, HS&E, etc.).

Exhibit detail oriented documentation skills to ensure Right-First-Time testing.

Support other laboratory activities as directed by laboratory manager.

In addition to the core responsibilities listed above, the jobholder may be required to perform other duties on an ad-hoc basis.

Preferred 1-2 years’ experience working in a pharmaceutical GMP environment.

Experience with HPLC and / or GC and working in a GMP laboratory environment is required.

Coordinate customer repairs Manage Document Change Control (DCR)

Manage product rentals and loaners

3-5 years’ experience in Quality Role.

Demonstrated Critical Thinking skills with focus on improved performance outcomes and positive business impact.

Working knowledge of FDA Quality System Regulations, ISO-13485.

Write and update Standard procedures in compliance to QMS

Time management and organizational skills being able to handle multiple priorities in a fast-paced environment

Field questions from various levels of management pertaining to testing results

Review and understand client specifications and benefit design builds through RxPlan and PharmScreens software platforms

Build/Run standard and custom batch claim files for clients in all lines of business and benefit design complexities

Perform benefit compare analysis between PharmScreens and RxPlan

Serve as point of contact for other departments troubleshooting plan/benefit configuration related questions through claims testing

• Defines appropriate testing methods to employ to assure developed application conforms to requirements and design

• Quality Certification, such as CSTE, CSQA, CMST, CSQE is a must

• Health Industry experience is Must

Senior IT Quality Control Analyst

How You Will Make an Impact:

• Coordinates/executes testing across multiple testing phases, including SIT, UAT, and Regression

• Extremely detail-oriented with strong technical skills.

• Ability to effectively manage multiple priorities involving aggressive timelines at a high level of productivity.

• Perform daily cGMP quality control laboratory microbiological testing activities at the iCTC facility.

• Perform environmental monitoring of the cleanroom areas as scheduled.

• Perform all activities with respect to cGMP compliance.

• Support thorough cGMP investigations for out-of-specification test results.

Time management and organizational skills being able to handle multiple priorities in a fast-paced environment

Field questions from various levels of management pertaining to testing results

Review and understand client specifications and benefit design builds through RxPlan and PharmScreens software platforms

Build/Run standard and custom batch claim files for clients in all lines of business and benefit design complexities

Perform benefit compare analysis between PharmScreens and RxPlan

Serve as point of contact for other departments troubleshooting plan/benefit configuration related questions through claims testing

Experience with research, project, and program management

3+ years of experience in science and/or information technology

Bachelor's degree or six (6) years of relevant work experience, or Associate's degree and four (4) years of relevant work experience

Experience managing complex projects including managing budgets

Excellent communication skills, both written and verbal

Support the development of cooperative agreement terms and conditions

Bachelor's degree in Accounting, Finance, or a related field or experience within the banking industry

Knowledge of banking regulations and compliance requirements

Strong analytical skills with attention to detail

Excellent communication and interpersonal skills

Conduct quality control reviews of banking operations and processes to ensure compliance with relevant laws and regulations

Identify deficiencies and recommend corrective actions to improve banking operations and processes

Participate in qualification of software and equipment.

Knowledge of operation and maintenance of analytical equipment and the associated software.

Perform routine projects independently, compile accompanying reports and/or data summaries.

Bachelor’s degree in Life Sciences/Biology/Chemistry or related discipline.

Self-driven, organized, adaptable to change, and can work independently under minimal supervision.

Vacation, sick time and holidays

Volunteer time to participate within your community

Paid sabbatical after 5 years; every 3 years thereafter

Here’s What You’ll Bring to the Table:

Generous paid time off, including:

Strong leadership and project management skills.

Self-starter with a working knowledge of quality management fundamentals, data analysis, and policy creation.

Strong analytical, organizational, time management, and decision making skills.

Evaluates and provides appropriate solutions for risk issues and presents to Senior and Executive Management.

Associate’s Degree in Business, Finance, or related field of study from an accredited four-year college or university or equivalent experience required.

Continuing education and career certifications

Knowledge of Current Good Manufacturing Practices (cGMP), Food and Drug Administration (FDA), and other regulatory requirements

Perform calibration, qualification and maintenance of laboratory equipment

Carries out responsibilities in accordance with the organization’s policies, procedures, and state, federal and local laws

Experience in Chemistry and Wet Chemistry

Experience in Sampling Methods, Quality Control Systems, and Sample Preparation Techniques

Competitive salary (based on experience)