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Quality Assurance / Document ControlSciecure Pharma Inc • Franklin Park, Illinois, United States
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Quality Assurance / Document Control

Sciecure Pharma Inc
  • US
    Franklin Park, Illinois, United States
  • US
    Franklin Park, Illinois, United States
Jetzt Bewerben

Über

Senior Formulation Scientist Overview: Senior Scientist in Formulation must be able to work independently from bench top development leading to successful submission and approval of ANDA and NDA (505b2). This role should also assist in supervising, guiding and following up junior scientists to achieve their respective goals.
Job Type: Full-time
Responsibilities:
Design and perform experiments leading to the development of rational, scientifically sound formulations and manufacturing processes
Provide leadership to scientist when appropriate
Support regulatory submissions as needed
Review compendial requirement for use of excipients and patent literature
Write master formulas, manufacturing procedures, stability reports, SOPs, and product development reports
Write specifications for finished products and packaging components
Design and Initiate stability studies on selected batches of products
Evaluate relevant characteristics of raw materials and experimental batches in an effort to develop robust manufacturing practices
Oversee the manufacturing of products using production equipment, such as batches for ANDA submissions, bio-equivalent studies, and/or process scale-up studies
Perform product/process validation when required; including designing procedures, overseeing batch sampling, and analyzing data
Coordinate with Analytical Department for completing testing of new drug products in a timely manner, and developing appropriate controls
Coordinate scheduling and production of pilot scale and submission batches with Manufacturing Operations and Quality systems
Support qualification, calibration, and maintenance of R&D instruments/equipment
Responsible for documentation of all activities as per cGMPs and cGLPs
Develop and maintain knowledge pertaining to cGMP documents and guidance, other FDA/ICH guidance and SOPs
Perform other tasks as assigned by the supervisor
Requirements:
Ph.D. in Pharmaceutics, Material Sciences, or related discipline with a minimum 2 years’ experience (or MS with 5+ years’ experience) in Drug Product development of small molecule oral liquid dosage form (solution/suspension/powder for oral suspension). Experiences in emulsion, nano/micro suspension and micro-encapsulation is preferred but not required
Strong oral and written communication skills, and possessing good interpersonal and team working skills
Demonstrate skill for problem solving, prioritizing objectives from multiple projects, and meeting the scheduled timelines while maintaining the attention to details
Analytical R&D Laboratory Scientist Overview: The Analytical R&D laboratory supports, development and validation of methods analytical test methods, evaluation and testing of raw materials, and testing of non-commercial materials to support product development. All activities are performed in accordance with specifications, standard operating procedures, approved test methods and/or protocols, regulatory requirements.
Job Type: Full-time
Responsibilities:
Analysis of finished products, in-process materials, raw materials, and cleaning verification and validation samples according to the assigned specifications, methods and protocols
Preparation of reagents/standards/media needed for analysis according to established methods
Disposal of hazardous waste by following environmental regulations and company/departmental procedures
Tabulation and interpretation of results of analysis as recorded in notebooks, reports and logbooks.
Assures right-first-time execution of departmental methods and SOPs
Audits and verifies results, including but not limited to, calculations in notebooks/logbooks and results in reports to check for accuracy and integrity of data
Writes and reviews analytical methods, deviations, protocols, SOPs and any other technical documents
Provides support for ordering and maintaining inventory of laboratory materials and equipment.
Performs other miscellaneous duties as required
Works flexible hours including weekends and evenings to accommodate the production / validation schedule
Qualifications:
Bachelor’s degree from four-year college or university in any of the following disciplines: Chemistry, Biology, Microbiology, or related sciences (as applicable)
Minimum of 1 year relevant pharmaceutical laboratory/analytical experience
Experience with common pharmaceutical laboratory equipment including, but not limited to, U.V. spectroscopy
HPLC, and GC instrumentation
Dissolution testing
Expertise in wet chemistry techniques such as titrations, extractions, digestions and preparations of test solutions
Knowledge of the following: Safety and hazardous waste requirements
cGMP cGLP standards
Quality Assurance / Document Control Overview: Quality Assurance / Document Control position available at Sciecure Pharma Inc. We are seeking an entry level or partially experienced QA Associate on a permanent basis. Considering local candidates with GMP experience in a manufacturing setting within the QA department.
Job Type: Full-time
Responsibilities:
Assist in the timely completion of Quality Assurance tasks and responsibilities.
Use and manage Quality spreadsheets, tracking sheets and checklists.
Become proficient in the following internal systems and activities: SOP's, Change Controls, Deviations, Corrective Actions, Training records, and record retention.
Process, circulate, review and catalog documents and approvals.
Organize and maintain the electronic storage of cGMP documents.
Provide support during inspections and audits.
Qualifications:
Entry level candidate with some experience in Quality Department (QC or QA).
Bachelor's degree in science or equivalent is required.
3 years of prior work experience in a Biotechnological, Pharmaceutical, or Clinical environment is required.
Some understanding of FDA guidelines and cGMP's.
Superior attention to detail with strong organizational skills.
Must be proficient with Microsoft Office applications.
Has the ability to handle multiple tasks in a timeline-driven environment.
Project Coordinator Overview: Sciecure Pharma Inc. specializes in the research and development of pharmaceutical finished products from conception to commercial. Our growing company is seeking to hire a project coordinator who will be in charge of assisting in organizing our ongoing projects. This task involves monitoring project plans, schedules, organizing and participating in stakeholder meetings, and ensuring that project deadlines are met in a timely manner. To be successful as a project coordinator, you will need to be able to work on tight deadlines, be competent in using Microsoft Office applications such as Word and Excel, and have exceptional verbal, written, and presentation skills. A bachelor’s degree in life science is required for consideration.
Job Type: Full-time
Responsibilities:
Maintaining and monitoring project plans and project schedules.
Organizing, attending, and participating in stakeholder meetings.
Documenting and following up on important actions and decisions from meetings.
Preparing necessary presentation materials for meetings.
Ensuring project deadlines are met.
Providing administrative support as needed.
Undertaking project tasks as required.
Ensuring projects adhere to frameworks and all documentation is maintained appropriately for each project.
Assist and ensure stakeholder views are managed towards the best solution.
Chair and facilitate meetings where appropriate and distribute minutes to all project team members.
Create and maintain a project management calendar for fulfilling each goal and objective.
Qualifications:
Bachelor’s degree in Life Science (Biology, Chemistry, Chemical Engineering, Etc.).
1 – 3 years of experience working in a cGMP environment is preferred.
Exceptional verbal, written, and presentation skills.
Ability to work effectively both independently and as part of a team.
Experience using computers for a variety of tasks.
Competency in Microsoft applications including Word, Excel, and Outlook.
Knowledge of file management, transcription, and other administrative procedures.
Ability to work on tight deadlines.
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  • Franklin Park, Illinois, United States

Sprachkenntnisse

  • English
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