QA Specialist

Division Overview

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.

Acrotech Biopharma is focused on building a presence in unmet needs in oncology and dermatology. We are currently building out a new Dermatology Business Unit to launch ADQUEY a novel treatment for mild to moderate Atopic Dermatitis.

This is a great time to join Acrotech. We are seeking talented leaders to grow our organization. Here you won't be just a number, but a key contributor who will make significant impact on our organization and the patients we support.

Job Overview

This 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 important. This role provides a unique opportunity to learn many aspects of Quality Assurance within an expanding company.

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.
• Compile, consolidate and review documents to prepare for and/or release product, including: Certificates of Analysis, Certificates of Conformance, Test and Batch Record Review Forms, Executed Batch Records, specifications, investigations and change controls.
• Review deviations, CAPA, complaint investigations and change controls for completeness, adequacy and adherence to SOPs.
• Author/Review SOPs.
• 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 create monthly metrics.
• Support client/regulatory audits/inspections as Scribe and process requests for documentation.
• Helps organize and prepare for audits/inspections. Helps to write/review observation responses. Review Status Updates to FDA.
• Perform additional duties as assigned by department management.
• Domestic and international travel possible <5%.

Qualifications - Skills & Requirements

• Essential skills include attention to detail; excellent organizational skills and critical thinking.
• Excellent communication skills - able to communicate clearly and concisely.
• Strong computer skills, including proficiency with MS Word, Excel, PowerPoint, and Outlook. Skills in SharePoint, Visio and Oracle a plus.

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
• Annual Bonus
• Long-term Incentive Plan
• Medical and Rx Benefits choice of four medical plans through Horizon. Rx automatically provided with medical benefits
• Dental Benefits with three dental plan options through CIGNA
• Vision Plan with two plan options through VSP
• Life Insurance, Basic Life and AD&D and Supplemental Life Insurance
• Disability Insurance, Voluntary Short-Term Disability and State Disability • Long-Term Disability (LTD), State (short term) disability - where applicable
• FSA (Flexible Spending Accounts) - Both Health Care & Dependent Care Available
• HSA (Health Savings Account)
• 401(k) Plan - Through Fidelity / Employer Match / fully vested after 3 years
• Employee Assistance Program (EAP) - 100% Confidential and 100% company paid
• Critical Illness and Accidental Insurance
• Legal and Identity Theft Insurance
• Paid Time Off - Paid vacation, PTO, Holiday

Notice to Recruitment Agencies:

Please note that we are not accepting unsolicited resumes or proposals from recruitment firms or agencies for this position. Thank you for your understanding.

Compensation

Min

USD $72,000.00/Yr.

Max

USD $81,000.00/Yr.

Physical Requirements

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.

Additional Physical Requirements

No Additional Requirements

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.