QA Deviation || Norwood, MA || Type-6+ Months Contract ||$50-75/hr||On-site

Job Role- QA Deviation

Employment Type-6+month contract
Pay rate-$50-75/hr
Location-Norwood, MA

Here’s What You’ll Do:

  • Write, review and approve GMP documentation (SOPs, protocols, technical reports, technology transfer protocols, specifications, summary reports to support GMP production, change controls, etc.)

  • Review batch records, associated testing records, and other documentation to ensure that all steps have been executed correctly, verified where applicable, and that all limits and specifications have been met

  • Develop and maintain Quality Agreements with contract manufacturers, suppliers, and laboratories

  • Review and approve validation protocols and reports to ensure compliance

  • Review protocols, analytical results, and documents associated with investigations, OOS results, etc., and corrective/preventive action plans

  • Support disposition of DNA plasmid materials

  • Review stability protocols and reports

  • Collaborate with Manufacturing and lead investigation teams to resolve equipment and process related deviations

  • Communicate project requirements and issues to Quality Management

  • Conduct internal audits, track progress, and trend results

  • Participate in supplier audits

  • Support the collection of data/metrics for Management Review

  • Support Contract Manufacturing sites and perform Person-in-Plant duties as required

  • Review relevant sections of regulatory filings

  • Provide guidance on GMP manufacturing from Phase I to Commercial

 

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

  • BS with at least 3 years’ experience, or a Master’s level degree and 1-2 years’ experience in the pharmaceutical/biotech industry within Quality Assurance or Quality (Assurance) exposure

  • Working knowledge of relevant FDA, EU, ICH guidelines and regulations.

  • Experience working with CMOs, vendors, and relationship management preferred.

  • Experience working with DNA plasmid materials manufacturing preferred.

  • Excellent judgment and ability to communicate complex issues in an understandable way.

  • Outstanding communication skills (verbal and written).

  • Auditing experience is a plus.

  • Familiarity with PDA Technical Reports 22, 26, 60, and 79 preferred.

  • Knowledge of late-stage pharmaceutical development and validation principles preferred

  • Ability to manage multiple projects in a fast-paced environment.

  • Ability to effectively collaborate effectively in a dynamic, cross-functional matrix environment.

 

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Business Analyst III (IT) || Swiftwater, PA || Type-4 Months Contract ||$45-50/hr||Remote

Job Role- Business Analyst IV (IT)

Employment Type-4-month contract
Pay rate-$45-50/hr
Location-Swiftwater, PA
Duties & Responsibilities
Overall business integration in iLearn of the various businesses using the legacy LMS.

This includes:
 Work with stream lead to confirm customer groups intake prioritization and schedule
 Engage with customer groups and plan business integration activities for example, workshops, ad-hoc meetings, etc…
 Review functionalities and services that will be used (within appropriate functional core model) and design the best way to use iLearn to meet the customer’s need. Perform demos and/or build mock-ups when needed
 Create and/or Contribute to the creation of the learning offerings
o Map course data to iLearn standard learning objects
o Work with customer groups and to identify or create supplemental learning object data (e.g. subjects, availability groups, assignments, etc)
o Prepare with customer groups the data required to build the training paths, the groups, the assignment and the other Learning Objects that cannot be migrated
 Coordinate with iLS the manual set up of curriculums, groups and assignments and/or other Los that cannot be migrated (pre go live activities)
 Coordinate checking by customers of the manual set up (curriculums, groups, assignments and other Los created manually)
 Service organization dimensioning and implementation
o Develop with the customer service volumes estimates for admin resource sizing
o Support the customer groups in assessing the best support model (centralized or decentralized) Identify with customer groups Authorized Requestors or decentralized admins
 Brief iLearn Services Operations and Learner support teams
 Attend decentralized admin training sessions when/if needed
 Support iLS in the hypercare period post go live
 Contribute to change management on topics specific to the stream (FAQs…)


Knowledge, Skills & Abilities
 Possess a strong understanding of the Cornerstone Learning Management System and associated functionality
 Strong Learning and Development background preferred
 Strong knowledge and experience in client implementation and testing methodology.
 Rigorous and quality oriented.
 Experience working with global system/environment.
 Ability to understand any business processes
 Good knowledge of IS technology in general.
 Ability to interact with project streams at any points of a project cycle and to take leadership when decision or prioritization are required.
 Ability to plan, set priority and manage several complex activities simultaneously while working under pressure to meet deadlines.
 Strong written and verbal communication skills to effectively address all level within the organizations (Learning, ITS, etc…) and identify resolutions.
 Assist in enforcement of project deadlines, schedules, and methodologies.
 Influencing skills
 Fluent English
 
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Project Leader IV (IT) || Bridgewater, NJ || Type-15-Months Contract ||$60-65/hr

Job Role- Project Leader IV (IT)

Employment Type-1-year contract
Pay rate-$60-65/hr
Location-Bridgewater, NJ
Description:

The primary purpose of this position is to function within the Information Solutions Department as a leader of the design, development, testing, documentation, validation, and support of approved IS business projects that will facilitate the development and management of systems within the Industrial Operations (IO) business process area with respect to information capture, storage, analysis and reporting. A person in this position may lead projects that are local, regional or global in scope, and that have extensive impact on the business. Examples of the types of systems that the individual will work with include data acquisition systems, document management systems, web applications, Laboratory Information Management Systems, manufacturing automation systems, SAP, etc. The majority of the positions responsibilities are related to system implementation tasks such as Business case development; Resource management (including proactive assignment of resources to IS projects); Leadership of project implementation teams; Development of project plans and day to day management of IS projects; Process design, business data, process, and workflow modeling; Software selection; Interaction with Sr. Business Analysts and Business Analysts who may manage day to day tasks at a more detailed level; Managing IS and other project team resources across multiple projects to get projects completed; Change management; Management of project budgets via capital and deferred software funds; Establishment and maintenance of a common framework to support application development, including project management standards, software configuration control, change management, user support and training, testing procedures, validation, and quality assurance; Coordinated reporting and presentation of project status, resource allocation, and other project-related information to IS management..

Years of Experience: 0 – 3 Years

 
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Quality Control Analyst I || Framingham, MA || Type-15 month Contract ||$28-30/hr

Job Title-Quality Control AnalystI

Location: Framingham, MA

Pay Rate: $28-30 per hour

Description:   
Position Summary
– This Quality Control Analyst I is responsible for performing routine testing of in-process
samples, stability samples and final products in accordance with SOPs for product
release.
Core Responsibilities
– Perform UV-Vis spectrophotometry, HPLC and Gel assays for in-process and final
product samples.
– Review of QC Data for compliance to procedures and specifications.
– Calculate and evaluate results.
– Successful completion of assigned training.
– Effectively demonstrate an understanding of cGMPs and application to specific
responsibilities:
– Follow accurate written procedures for testing of in-process and final product samples.
– Provide input to the technical composition of operating documentation.
– Work independently under general supervision and direction.
– Work in compliance with CGMPs.
– Practice safe work habits and adhere to Sanofi’s safety procedures and guidelines.
– Perform maintenance on basic laboratory equipment.

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Supply Chain Analyst II || Chattanooga, Tennessee || Type-18- months Contract ||$40-45/hr

Job Role- Supply Chain Analyst II

Employment Type-18-months contract
Pay rate-$40-45/hr
Location-Chattanooga,Tennessee
Description:
This role is to support Project CHLOE

Role Specific Responsibilities

• Provide reports to monitor key performance indicators (KPI’s) with the objective to continuously improve visibility and performance of the department
• Support Inventory Deployment through analysis to balance Inventory among the DC’s
• Monitor and report on Ingredient inventory and provide closeout direction
• Assist Cycle Counter with high value counts and miscellaneous inventory adjustments
• Audit and revise Item Master Data, Bills of Material, and Routings within JD Edwards (JDE) system
• Develop, monitor, and close Manufacturing and Packaging Batch Records for internal production and Packaging Specifications for third party manufacturer production
• Coordinate material transfers for third party manufacturer assembly/production projects
• Coordinate inbound shipments and batch records for third party manufacturers
• Plan and implement packaging and/or product changes consistent with Marketing objectives, while minimizing inventory obsolescence
• Assist with data collection, analysis and recommendations for efficiency and cost savings throughout the Supply Chain
• Develop and implement 12-month rolling Master Production Schedule (MPS) and Capacity Plan based upon Operation’s Sales Forecast
• Convert MPS into detailed production line schedule for short range (2-3 months) horizon balancing inventory needs, capacity utilization and changeover impact
• Provide component/ingredients needs to Materials Planning or Procurement from Materials Requirement Plan (MRP)
• Provide demand planning reports to monitor key forecast metrics with the objective to continuously reduce forecast error
• Use and maintain the operations (demand) forecast
• Provide timely and accurate item level forecast changes to the production planners
• Other similar duties as determined by their Manager
• Undertake special projects as requested
 
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