Job Description

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.

The above information in this description has been designed to indicate the general nature and level of work performed by employees within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities, and qualifications required of employees assigned to this job.