9 Jobs in East Windsor, NJ
Acrotech Biopharma Inc is Hiring a Quality Assurance Specialist Near East Windsor, NJ
Acrotech Biopharma Inc., was formed as a global platform to commercialize innovative proprietary medications. The company aims to launch scientifically advanced products to address unmet needs and deliver value to patient's as well as all healthcare stakeholders. Acrotech aspires to be a patient focused, research based organization that strives to launch treatments which are accessible to patients that need them.
Job OverviewThis position provides support to various functions within Quality Assurance and reports directly to the Sr. Director of Quality Assurance. Responsibilities include the creation, organization, and review of GXP documentation, (e.g. change controls, specifications, protocols, SOPs and reports), and assisting with the coordination of training and budget activities, including purchase orders and invoices. The role assists QA product managers with responsibilities of overseeing contracted manufacturers and marketing partners, in an environment where all manufacturing/testing is contracted. This role primarily consists of ensuring documents are formatted properly, well organized in our electronic repository and readily retrievable. The successful candidate will ensure documents provided to internal/external customers are accurate, clear, and in line with Acrotech SOPs. The Specialist will also help ensure that proposed changes consider the impact to other processes, documents, budget items and external partners through a full understanding of Acrotech’s processes. Based on a candidate’s knowledge and experience, the role may expand into other functions as well. The ability to assist with drafting clear SOPs is preferred. This role provides a unique opportunity to learn many aspects of Quality Assurance with a small company.
This position is on-site at the Corporate headquarters in East Windsor, NJ, in an office environment.Responsibilities
- Organize documentation and ensure ease of identification and retrieval
- Assist in the issuance of purchase orders, invoices, and budget development
- Assist managers in the organizing, maintenance, writing and review of GxP documents related to products, production, and CMO/CTO (contractor) oversight
- Consolidate and review documents to prepare for and/or release product, including: Certificates of Analysis, Certificates of Conformance, Test and Batch Record Review Forms, investigations and change controls
- Assist the review of i deviations, complaint investigations and change controls
- Author/Review SOPs & specifications
- Compile final documents related to batch production and release
- Assist with tracking the stability & reference standard programs at contractors
- Consolidate documentation/data for Annual Product Reviews (APRs) and trend stability data
- Track activities and support the creation of monthly metrics
- Technical Support for marketing partners
- Support client/regulatory audits/inspections and requests for documentation
- Perform additional duties as assigned by department management
Education & Experience
- 3 years of experience in a GMP environment such as a Pharmaceutical Industry
- Bachelor’s Degree in chemistry, life sciences or related field with analytical laboratory experience a plus
OFFICE POSITION - While performing the duties of this job the employee is required to:
- Stand, sit; talk, hear, and use hands and fingers to operate a computer and telephone keyboard reach, stoop kneel to install computer equipment
- Specific vision abilities required by this job include close vision requirements due to computer work
- Light to moderate lifting is required
- Moderate noise (i.e. business office with computers, phone, and printers, light traffic).
- Ability to sit at a computer terminal for an extended period of time Sedentary work Exerting up to 10 pounds of force occasionally and/or negligible amount of force frequently or constantly to lift, carry, push, pull or otherwise move objects, including the human body. Sedentary work involves sitting most of the time. Jobs are sedentary if walking and standing are required only occasionally and all other sedentary criteria are met.
Blood/Fluid Exposure Risk
Category III: Tasks involve no exposure to blood, body fluids or tissues. Category I tasks are not a condition of employment.
Job Summary
Full Time
Pharmaceutical
$97k-116k (estimate)
04/23/2023
06/14/2024
The job skills required for Quality Assurance Specialist include Analysis, SOP, Microsoft Office, Change Control, Communication Skills, Chemistry, etc. Having related job skills and expertise will give you an advantage when applying to be a Quality Assurance Specialist. That makes you unique and can impact how much salary you can get paid. Below are job openings related to skills required by Quality Assurance Specialist. Select any job title you are interested in and start to search job requirements.
The following is the career advancement route for Quality Assurance Specialist positions, which can be used as a reference in future career path planning. As a Quality Assurance Specialist, it can be promoted into senior positions as a Quality Assurance Specialist IV that are expected to handle more key tasks, people in this role will get a higher salary paid than an ordinary Quality Assurance Specialist. You can explore the career advancement for a Quality Assurance Specialist below and select your interested title to get hiring information.
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