QC & ARD Chemist
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.
Send resume to:
Brillian Pharma Inc.
HR Department
11 Deer Park Drive, STE 120
Monmouth Junction NJ, 08852
Equal Opportunity Employer
Brillian Pharma Inc. is an equal opportunity employer (EEO). We do not discriminate in hiring on the basis of sex, gender identity, sexual orientation, race, color, religious creed, national origin, physical or mental disability, protected veteran status, or any other characteristic protected by federal, state, or local law.