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QUALITY ASSURANCE- TECHNICAL QUALITY OPERATIONS SPECIALIST
RESPONSIBILITIES:
- Review and approve all technical documentation including Deviations, Complaint Investigations, and CAPA.
- Review and approve all R & D protocols and reports, validation and qualifications and reports, validation and qualification protocols and reports, and change control justifications.
- Schedule, perform, and report on internal and external quality audits. Recommend corrective action where necessary.
- Generate and review documentation associated with the Annual Product Review process.
- Act as a liaison between QA and other departments on technical issues.
- Identify quality process improvements to increase efficiencies and performance of systems, operations, and personnel.
QUALIFICATIONS:
- Bachelor’s Degree in scientific discipline
- 5+ years experience in a pharmaceutical setting
- Strong working knowledge of Federal (FDA) Good Manufacturing Practice (GMP) requirements, guidelines, and documentation practices
- Strong technical writing skills, strong oral and written communication skills
QUALITY ASSURANCE INSPECTOR
RESPONSIBILITIES:
- Ensure inspection activities being performed by SOPs and cGMPs including but not limited to inspection, sampling and release of raw materials, printed material, components, marketing and finished goods.
- Perform and maintain performance monitoring program of packaging materials. Responsibilities include but not limited to dimensional, functional and chemical testing.
- Sample non-hazardous and hazardous raw material. Responsibilities include but not limited maintaining: raw material sample room, retention sampling and particle monitoring.
- Ensure printed material (includes labeling) comply with component specifications/drawings (or artwork). Responsibilities include but not limited to label count, verification of bar code and artwork.
- Process/review documentation for accuracy and compliance to Good Documentation Practices.
QUALIFICATIONS:
- High School Diploma or GED
- Previous experience in a manufacturing, receiving, inspection environment preferred
- Familiar with standard concepts, practices, and procedures associated with Quality Control
- Detail oriented, self motivated, able to work independently and quality minded
- Good communication skills (verbal and written)
TRAINING SPECIALIST
RESPONSIBILITIES:
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Assist in the development of training programs, including companywide and department specific programs.
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Conduct cGMP training.
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Conduct new hire orientation.
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Conduct training on the use of IsoTrain System.
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Maintain Isotrain Management system.
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Communicate with all departments on required training, revisions, and new curriculums.
QUALIFICATIONS:
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Bachelor's Degree in a related area or equivalent in education or experience.
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Previous experience in developing training programs for adult learners.
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Computer proficiency in MS Word, Excel, Access.
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Working knowledge of Federal (FDA) Good Manufacturing Practice (GMP) requirements and guidelines.
PRODUCTION EQUIPMENT MECHANIC
RESPONSIBILITIES:
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Set-up, troubleshoots, maintain, and repair of all high speed labeling, packaging and inspection equipment
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Troubleshoot/repair/replace a Printed Circuit Board (PCB) to component level. Familiarity with vision systems favorable.
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Execute in a timely fashion equipment preventative maintenance for maximum productivity and efficiency.
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Maintain, set up, troubleshoot, and repair all glass vial and ampoule filling and washing machines and glass handling equipment located within the Wash area and the A.P.A.
Qualifications:
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High school diploma or equivalent. Vocational or trade school certification accepted.
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Strong electro/mechanical background with experience in troubleshooting and using electrical and electronic control testing devices i.e. meters and scopes
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Must have a working knowledge of the operation of Programmable Logic Controller (PLC) and I/O circuitry.
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Must have experience in reading and understanding electrical and PCB control schematics
TERRITORY MANAGER, MULTIPLE TERRITORIES INCLUDING PA, NJ, AL, and LA
Join Regency Therapeutics, a newly formed division of Luitpold Pharmaceuticals promoting a non-narcotic, opioid level pain medication. As a new division within the branded pharmaceutical industry this position offers the opportunity for experienced sales representatives to utilize their entrepreneurial skills in the development of their territory. Regency Therapeutics abides by all PHRMA Code and FDA policies while offering the ability to provide feedback as the division develops.
Territory Manager Position requires the individual to:
- Define and achieve sales objectives for the Company’s products in the territory assigned.
- Call on target physicians to sell division’s products through personal presentations and all other appropriate means.
- Prepare and present an annual territory sales plan, analyzing each market segment to determine market potential, division product’s market share, problems and opportunities, develop strategies and tactics to meet the sales objectives.
- Gather and record individual account market data, through daily input into the approved CRM system database, reporting daily activities.
- Synchronize CRM territory data daily with headquarters sales data, in order to maintain up to date account information for proper pre-call planning.
- Identify, interact with and support Key Opinion Leaders in assigned territory, maintaining frequent contact with division marketing department to communicate knowledge about developments in the US market, opportunities and requests from KOL’s.
- Monitor competitors marketing claims and product positioning strategies; propose and implement appropriate marketing claims and product positioning strategies.
- Manage territory selling expenses within approved budget.
- Prepare and transmit required administrative work (expense reports, activity reports, etc.) in accordance with company policies and in a timely manner.
Qualifications:
- BS College degree or equivalent experience.
- Successful sales experience, Pharmaceutical market experience preferred, specifically recent experience in calling on surgical specialties and/or emergency room physicians.
- Computer literate (Windows, Words, Excel, Power Point).
- Excellent oral and written communication skills
- Self-motivated.
CLINICAL RESEARCH ASSOCIATE, NORRISTOWN, PA FACILITY
- Assist with Administration of clinical research projects: recruiting, investigators, collecting investigator documentation, site management, site monitoring, preparing status reports and completing other technical tasks to completion.
- Initiate, monitor and close-out clinical investigative sites under supervision from Project Managers, Clinical Regulatory Managers, and Medical Directors.
- Provide ongoing assistance and education of investigational sites in principles of Good Clinical Practice (GCP) as it relates to Research involving human subjects.
- Ensure subject safety through diligent monitoring of the site’s compliance with study protocols and the collection of adverse event information
- Update, track and maintain study specific trial management tools/system.
- Monitor Case Report Forms (CRF) for missing implausible data. Assess compliance with study drug handling procedures. Ensure that all adverse events are collected pursuant to GCP.
- Report, write narratives and follow-up on reported serious adverse experiences.
- Assist with generation and reconciliation of queries to investigation sites to resolve problem data.
- Assist and manage project budget and investigator site budget, attend project team meetings, plan and attend investigator meetings, and communicate with clients.
- Generate and track drug shipments and storage.
- Provide coverage to clinical contact telephone lines. Provide answers to common protocol related questions under the supervision of the Project Manager and Medical Director.
QUALIFICATIONS:
- Bachelor’s degree required. Preferred degree in the Biological / Health Sciences. Pharmaceutical industry experience a plus.
- Minimum 1 year experience in Drug Development, Regulatory Affairs, CRA experience a plus. Dialysis, Rheumatology, Oncology, Cardiology, Pediatrics or GI experience preferred
- Ability to travel up to 80%, including overnight
- Strong multi-tasking abilities and able successfully handle multiple priorities simultaneously. Detail oriented, self-motivated
- Proficiency in MS Word, Excel and Outlook. Knowledge of Medical/Regulatory Terminology
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