QA Technician- Warehouse Operations at Granules Pharmaceuticals

Manassas, Virginia, United States -

Full Time

Start Date

Immediate

Expiry Date

30 Sep, 26

Salary

25.0

Posted On

02 Jul, 26

Experience

2 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

cGMP Compliance, Quality Assurance, Incoming Inspection, Sampling, Inventory Control, SAP, Warehouse Management System, Good Documentation Practices, CAPA, Change Control, Technical Writing, Cross-functional Communication

Industry

Pharmaceutical Manufacturing

Description

Description Granules Consumer Health LLC is a subsidiary of Granules India LTD, a vertically integrated pharmaceutical company with headquarters in Hyderabad, India. Granules Consumer Health LLC is located in Chantilly, Virginia. We have 106 employees and annual revenue of $76.64 million. We serve as Granules’ front-end division for private label over the counter (OTC) products in the US. We offer OTC generics that meet the highest level of quality at an affordable cost. As such, we are well-established on bulk supply through efficiencies garnered through manufacturing, integration and a high level of regulatory compliance. We are dedicated to excellence in manufacturing, quality, and customer service. Summary The QA Technician- Warehouse Operations for documentation at Granules Consumer Health ensures compliance with cGMP and internal policies, procedures, and specifications. This position is responsible for performing QA incoming inspections, release, sampling and shipments review, inventory control and quality system functions in accordance with cGMP and related company SOP’s, state, federal and local laws as applicable. This person should be knowledgeable of cGMP requirements, FDA regulations and ICH guidelines, SAP and Warehouse Management System. Job Duties & Responsibilities · The QA Warehouse Operations is responsible for quality activities supporting Warehouse Operations in accordance with Granules policies, standards, procedures and Global cGMPs. · Responsible for inspection of bulk, packaging components, packaged finished product, raw materials, and outgoing product. · Responsible for sampling of bulk, packaging components, printed packaging components, finished products and raw materials. · Responsible for ensuring GMP warehouse compliance with applicable procedures, providing real-time review of warehouse records and logbooks, and working with Warehouse Operations to resolve issues. · Ability to follow data that affects quality of materials, such as environmental/temperature tracking. · Archive and maintain hardcopy and electronic copies of label files and change history files. · Responsible for issuance, control and management of printed packaging components. · Responsible for Control and management of stability, retain and reject materials. · Assist in copying and scanning of documents as needed. · Build and maintain relationships with Warehouse Operations, Supply Chain and other departments to effectively accomplish responsibilities, make improvements and resolve issues. · Ensure compliance with GMPs, Good Documentation Practices, applicable procedures and warehouse requirements for storage, documentation, material handling, safe equipment operation, etc · Ensure standard operating procedures are periodically reviewed for relevance and accuracy in compliance with company policies and procedures. · Collaborate with team members to ensure timely deliverables for documentation. · Perform and support maintenance and closure activities of documents such as reports, protocols exceptions/deviations, CAPAs, change controls and complaints. · Must be flexible with working hours and able to work weekends and off hours as needed to support the patient. · cGMP Compliance of the facility. · Any other activity as assigned by the Supervisor. Reports to QA Manager Requirements Knowledge & Skills cGMP compliance within the pharmaceutical manufacturing industry. Writing and maintaining cGMP documentation. Analyze data/information and resolve complex issues. Verbal and written communication skills. Work and communicate with cross-functional teams. Multiple priorities and re-prioritize tasks. Experience & Education At least two (2) years’ experience in a quality assurance role in a cGMP-regulated environment. A college Degree preferably in sciences (i.e. Pharmacy, Biology, Chemistry etc.) Physical Requirements/Working Environment While performing the duties of this job, the employee is regularly required to, stand, sit, talk, hear, and use hands and fingers to operate a computer and telephone keyboard. Specific vision abilities required by this job include close vision requirements due to computer work. Ability to sit at a computer terminal for an extended period of time. Light to moderate lifting up to 10-15 lbs. is required. Ability to work in a confined area. We believe in fair and transparent pay practices. Actual compensation is determined based on relevant experience, qualifications, skills, and internal equity.

Responsibilities

The QA Technician ensures warehouse compliance with cGMP and internal policies through inspections, sampling, and review of shipments and records. They are also responsible for managing printed packaging components, stability materials, and supporting quality system functions like CAPAs and change controls.