Document Reviewer Job at PAI Holdings LLC
Be a part of our next generation…
We’re more than a pharmaceutical company, we’re a talented, passionate family helping people feel better.
We know it’s our employees (associates or something more contemporary) who help us make a real difference; and you will sense our welcoming, collaborative spirit the minute you walk through our doors.
We are ONE family, ONE PAI Pharma:
- Proud of our heritage and culture steeped in respect and equality.
- A leader in innovation, quality, safety and productivity.
- At the forefront leveraging cutting-edge technologies to produce better-targeted suspensions, oral solutions, elixirs, syrups and liquids.
- Embracing business practices that minimally impact the environment.
- Supporting our local communities.
- Fostering a safe, diverse and welcoming environment for all.
We want you to thrive — on the job and at home — and offer a comprehensive benefits package that includes health, dental and vision, 401(k), life insurance, wellness programs, vacation, sick leave, 104 hours holiday pay, employee assistance program, tuition reimbursement and more!
For over 50 years, we have been ONE Team continuously evolving and growing, and we hope you’ll join us.
Ready to join the family?
About PAI Pharma
PAI offers a broad portfolio of more than 60 prescription and over-the-counter therapies to treat patients. Some of our core strengths include brain, immune, metabolic and digestive health. For the OTC market, we provide a wide variety of affordable medications to treat allergies and upper respiratory symptoms, minor aches and pains, constipation and more.
To meet the unique needs of retail chains and independent pharmacies, hospitals, long-term care facilities and government agencies, PAI offers standard bottle packaging and ready-to-dispense packaging. In fact, PAI was the first independent manufacturer to develop vertically-integrated unit dose (UD) packaging, and the first to offer complete lines of hard-to-find liquid products in both out-patient and UD packaging.
Among North America’s leaders in quality, safety and productivity, Pharmaceutical Associates Inc. manufactures and markets generic liquid pharmaceuticals. We have been at the forefront of producing better-targeted suspensions, oral solutions, elixirs, syrups and liquids for 50 years.
PAI offers a broad portfolio of more than 60 prescription and over-the-counter therapies to treat patients. Some of our core strengths include brain, immune, metabolic and digestive health. For the OTC market, we provide a wide variety of affordable medications to treat allergies and upper respiratory symptoms, minor aches and pains, constipation and more.
To meet the unique needs of retail chains and independent pharmacies, hospitals, long-term care facilities and government agencies, PAI offers standard bottle packaging and ready-to-dispense packaging. In fact, PAI was the first independent manufacturer to develop vertically-integrated unit dose (UD) packaging, and the first to offer complete lines of hard-to-find liquid products in both out-patient and UD packaging.
We offer an excellent benefits package to include health, dental and vision, 401(k), life insurance, wellness programs, vacation, sick leave, 80 hours holiday pay, employee assistance program, tuition reimbursement and more!
Responsible for the document review of bulk and packaged products, raw materials and stabilities. The essential duties and responsibilities listed below are representative of those required on the job. Reasonable accommodations may be made to enable qualified individuals with disabilities to perform the essential duties and responsibilities.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
This position is responsible for reviewing the basic and (complex) analytical documentation of drug product and drug substance testing performed by QC analysts in a timely and compliant manner, as instructed by QC Management, per PAI finished product and stability specifications and USP methodology to ensure finished goods are acceptable for distribution.
- Responsible for ensuring QC documentation of all analyses was performed per cGMP and FDA guidelines.
- Responsible for performing monthly reviews of QC logbooks to ensure all entries are cGMP compliant.
- Responsible for verifying entry of data into LIMS system.
- Review instrumentation and equipment calibrations on an as needed basis.
- Responsible for document review of routine laboratory functions to support manufacturing/production and assure that production schedule is met.
- Responsible for maintain clean or organized work space.
- Accountable for the accuracy and timeliness of work.
Reviewer II: Advise QC Chemists on documentation practices and corrections with management oversight.
- Reviewer II: Assist in writing and revising Raw Material Specifications and Finished Product and Stability Specifications to ensure cGMP compliance.
- Perform other duties as assigned.
EDUCATION AND/OR EXPERIENCE:
This position requires a Bachelors’ degree in chemistry, biology or other science field. Plus 2 years of related experience and/or training. Working knowledge of Microsoft Office Suite is required. Chromatographic software such as OpenLab, Empower and LIMS software is preferred.
KNOWLEDGE, SKILLS & ABILITIES:
This position requires the individual be organized, detail-oriented, and self-motivated and to apply advanced mathematical concepts and operations. The ability to apply principles of logical and scientific thinking to a wide range of intellectual and practical problems. Decision making, communication, planning and critical thinking skills are a must. Analytical ability / problem solving, along with accuracy is required.
PHYSICAL REQUIREMENTS/WORKING CONDITIONS:
The physical requirements and working conditions listed for this job are representative of those required on the job. Reasonable accommodations may be made to enable qualified individuals with disabilities to perform the essential duties and responsibilities. Computer keyboarding, computer monitor and mouse use including reaching forward, grasping, finger and wrist manipulations, and neck bending and turning: near vision is necessary for computer monitor use. Frequently required to stand, sit, walk, talk and hear, occasionally required to reach with hands and arms, climb or balance, stoop, kneel, crouch or crawl. Occasionally lift up to 10lbs. This position may be occasionally exposed to toxic chemicals.
PAI is an Equal Opportunity Employer. PAI uses E-Verify.
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