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Business Administrator
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Position Summary:
Process transactions, handle inquiries, and maintain records for Accounts Payable, using standard practices. Support A/R collections. Prepare accounting reports and spreadsheets. Work under minimal supervision following established procedures along with own judgement.
Responsibilities:
- Accounts Payable - Process payables, resolve vendor inquiries, research open purchase orders, reconcile bank statements and unbilled receipts.
- Accounts Receivable - Process account receivables, collections. Process and verify cash receipts. Resolve customer invoice inquiries.
- Create capital transaction reports.
- Provide back-up Customer Service as required.
- Provide support for the Finance Manager.
Education and Experience Required:
- Associates Degree in Accounting required, Bachelors' preferred.
- Solid MS Office skills with a strong emphasis on Excel.
Skills Required:
- Ability to work with financial reports and figures.
- Strong and effective communication skills.
- Strong computer skills.
- Ability to plan, prioritize, and organize a diversified workload.
- Accounting software experience a plus.
Interested? Apply for this job online by attaching resume in Microsoft Word or Adobe PDF format at:
careers@pharmalucence.com
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Production Supervisor - Packaging
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Position Summary:
Plan, schedule and expedite the inspection, labeling and packaging of kit products to meet sales requirements according to current Good Manufacturing Practices (cGMPs) and following Standard Operation Procedures (SOPs). Manage all kit packaging operations in accordance with direction from Section Supervisor, and commercial forecast. Solve routine to complex production/process problems. Revise methods and procedures as needed to improve efficiency and quality of manufacturing/packaging process. Ensure proper operation of production equipment. Make recommendations on efficiency and cost as appropriate. Maintain a high level of presence in the inspection/packaging areas to manage personnel for optimal performance. Works under minimal direct supervision, utilizing some standard procedures along with own judgment.
Responsibilities:
- Resolve production/packaging issues and/or equipment problems with staff and/or other departments in a timely fashion.
- Directly oversee through regular presence in the inspection/packaging areas, packaging personnel to optimally manage performance.
- Update computer data for packaging department to record production
inventory, results, dates, problems, etc.
- Inspect all in-process documentation for accuracy.
- Plan and order supplies for production to assure the timely
completion of production goals.
- Assign daily duties to group to accomplish production goals
utilizing personnel most effectively.
Education and Experience Required:
- Bachelor’s Degree with 2 years directly related experience.
- Direct supervisory experience (lead person).
- Experience with automated packaging equipment.
- Visual inspection for SVPs.
Skills Required:
- Ability to solve routine process problems.
- Ability to manage a small group (5-7 employees).
- Strong knowledge of cGMPs.
- Excellent organizational skills.
- General computer knowledge.
Interested? Apply for this job online by attaching resume in Microsoft Word or Adobe PDF format at:
careers@pharmalucence.com
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RA/QA Compliance & Records Specialist
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Position Summary:
The RA/QA Compliance & Records Specialist is responsible for establishing and maintaining a modern records management system in adherence to the organizations quality management system; regulatory requirements (e.g. FDA cGMP, QSR, ISO13485); customer agreements; and business requirements.
This role will provide strategic direction of the records lifecycle management program (involving a combination of paper and electronic records) and will assist in managing domestic and international regulatory applications; mandatory reports; and licensing projects/activities as assigned. The scope of this position requires involvement and service to all core business units: research & development, manufacturing, quality control, engineering, IT, regulatory, and quality assurance.
Responsibilities:
- Enhance and oversee a company-wide record retention and archival program (e.g. the identification, on/off-site storage, protection, preservation, retrieval, retention and disposition of all controlled records).
- Establish and maintain the process of converting paper records into secured electronic records (e.g. PDF file format) in adherence to applicable regulatory requirements (e.g. 21 CFR Part 11).
- Provide support in the management, qualification, implementation, and process control involving domestic and international regulatory submissions, applications; mandatory reports; and licensing.
- Review, approve and provide guidance for labeling and advertising/marketing materials.
- Assist the RA/QA team in the evaluation, selection, and validation of additional RA/QA electronic systems as assigned, utilizing current technologies to ensure efficiency and compliance.
- Ensure regulatory compliance and promote a company-wide understanding of records lifecycle management through:
- Development, maintenance and implementation of documented processes.
- Design and provide employee training.
- Measure and monitor related metrics to drive improvement and achieve goals.
- Remain current with recent regulations and guidance documentation.
- Perform other regulatory and quality assurance duties, as assigned.
Education and Experience:
- BS in life science, computer science, library science preferred; or equivalent professional work experience of 5+ years in the pharmaceutical or medical device industry.
Skills Required:
- Expert level computer skills (e.g. Microsoft Office Applications, Adobe Acrobat, Lotus Notes).
- Working knowledge of regulatory record requirements (e.g. ISO 13485, FDA QSR, cGMPs, 21 CFR Part 11).
- Ability to articulate vision and strategy to executive management, peers, and subordinates in order gain quality systems compliance, commitment, and results.
- Strong project management talent; ability to meet and drive completion of timelines.
- Archiving Fundamentals - librarian attributes; highly organized; detailed; service oriented; creative thinker.
- Excellent communication skills (written and verbal); competent in technical writing; team player; takes initiative.
- Working knowledge and experience in the following areas are a plus:
o Structured Product Labeling (SPL) and Electronic Common Technical Document (eCTD).
o Electronic Data Management Systems (EDMS).
o Risk Management & Mitigation.
o Developing, reviewing, and/or approving validation protocol.
- Familiar with additional industry standards and regulatory requirements (e.g. ICH, USP, EMEA, NRC).
Interested? Apply for this job online by attaching resume in Microsoft Word or Adobe PDF format at:
careers@pharmalucence.com
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Production Manager
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Position Summary:
Plan and schedule production activities in the aseptic manufacturing area to meet sales requirements as set by commercial operations. Manage device manufacturing and pharmaceutical packaging operations in coordination with aseptic manufacturing. Responsibilities include ordering and tracking raw materials, as well as carrying out production of pharmaceutical kits and Active Pharmaceutical Ingredients (API) according to current Good Manufacturing Practices (cGMPs). Work with engineering group to revise methods/procedures, as needed, to improve efficiency and quality of manufacturing process while ensuring proper operation of production equipment/utilities. Oversee all parenteral kit and device production. Works under limited supervision.
Responsibilities:
- Plan production and delegate duties to drug and device personnel.
- Review batch records. Write and revise SOPs and other documents as needed in accordance with cGMPs.
- Order supplies in a timely fashion to assure there will be no interruption of production.
- Following SOPs and in accordance with cGMPs, carry out pharmaceutical manufacturing.
- Assure that personnel are trained per cGMP regulations for the jobs they are performing.
- Make recommendations and perform follow up on efficiency and cost improvements
- Ensure safety of work environment for production personnel.
- Works with QA, reviews current operational standards for compliance with current quality guidelines.
Education and Experience:
- Bachelor's Degree in biology, chemistry, operations, management or medical technology.
- 5-10 years experience with quality systems/aseptic manufacturing.
- 2-4 years supervisory experience.
- Working knowledge of cGMP.
Skills Required:
- Strong organization skills.
- Supervisory skills.
- Communication skills (oral and technical writing).
- Working with radioactive materials.
- Computer skills.
Interested? Apply for this job online by attaching resume in Microsoft Word or Adobe PDF format at:
careers@pharmalucence.com
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Regulatory Affairs Manager
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Position Summary:
Manage and oversee the regulatory process for medical products requiring governmental approval, including filing necessary applications and handling all government interactions to obtain timely approval. Coordinate inspection of the organization and contract facilities, and develop procedures to ensure regulatory compliance. The position leads and directs the work of others, relies on extensive experience, and judgment to plan and accomplish goals and exhibits a wide degree of creativity and latitude.
Responsibilities:
- Manage product A/NDA regulatory dossiers both domestic and international.
- Ensure rapid and effective development and review of regulatory documents to be submitted to the FDA and international regulatory agencies.
- Develop, implement, and adjust, as needed, regulatory strategies during the development phases of the assigned project(s). Recommend regulatory strategy in accordance with current regulations and guidance.
- Interface with Regulatory Agencies, answering regulatory questions. Assist in regulatory authority inspections and related responses.
- Oversee maintenance of department databases and perform electronic publishing of submissions. Manage internal file management for product submission files, storage and archiving domestic and international.
- Oversee annual product review, FDA Annual and ADE reporting processes.
- Coordinate with preclinical, clinical, medical affairs, manufacturing and quality systems groups to ensure regulatory submissions are reviewed and approved to meet project target dates.
- Develop and implement company regulatory policies and procedures and provide regulatory guidance to functional areas and project teams with regulatory input.
- Develop and maintain compliance to regulatory requirements and ICH guidance both domestic and international.
- Update licensing and collect information on registration instructions and regulations both domestic and international.
- Represent RA on label review and complaint committees.
- Coordinate RA contract manufacturing efforts.
- Coordinate comments to draft guidelines and provide Regulatory Department’s interpretation of guidelines to functional areas, as needed.
- Conduct product risk assessments.
Education and Experience:
- BS in a life science is required; MS pr PhD preferred.
- 8 + years Regulatory experience in FDA regulated industry.
- Strong knowledge of pharmaceutical and medical device documentation and change controls.
- CGMP auditing experience in conducting and preparing responses to both internal and agency audits.
- Experience with A/NDA, CMC, 510(k), or other agency submissions and familiarity with associated regulations.
- Strong background in document and change control.
- Some experience with clinical sections of NDA required.
- Pharmacovigilance (AE) reporting experience preferred.
- Product label review and approval management experience preferred.
- Successful CMC application experience with post approval drug products.
- Experience with managing regulatory files.
- Experience with international product dossiers preferred.
- Ability to execute risk management.
Skills Required:
- Requires ability to provide creative and compliant regulatory strategy for product risk management.
- Requires ability to work openly with teams to identify and resolve problems.
- Extensive knowledge of cGMPs and ISO standards.
- Demonstrated quality auditing skills/training.
- Familiarity with Lotus Notes-based quality systems and/or other electronic quality systems/databases.
- Excellent communication skills and word processing skills.
- Demonstrated supervisory/managerial skill.
- Requires interaction with all levels of company personnel to complete company goals.
- Requires self motivation.
Interested? Apply for this job online by attaching resume in Microsoft Word or Adobe PDF format at:
careers@pharmalucence.com
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