QC Technical Reviewer

Division Overview

Aurolife was founded in 2008 as part of a group of companies that has a long history of excelling in generic pharmaceutical product development and manufacturing. Aurolife has a 10 year history of extraordinary manufacturing practices in the solid oral dose arena. The support and expertise of our parent organization has given Aurolife a jump start in building a solid pharmaceutical portfolio very quickly. The Aurolife family consists of an experienced management team with expertise in manufacturing, R&D, Quality Assurance and Quality control and regulatory affairs. In addition to several formulations under manufacture, we have a robust pipeline of products. Aurolife's aim is to provide healthcare at economical prices to make this a healthier world to live in.

Job Overview

This position is responsible for the technical review of raw data, qualification protocols, Certificate of Analyses and other technical documents for the release of raw materials, finished products and stability monitoring. Functions will include supporting Laboratory investigations and writing technical reports for method transfers/verifications as it pertains to components, raw materials and finished pharmaceutical products. This positions supports ensuring compliance with standard operating procedure and all regulatory requirements that may arise. This position is responsible for providing training to department employees as required stemming from deviations and/or laboratory investigations. This position will also reponsible for anyother compliance task assigned by the department Head.

Responsibilities

• Technical review of raw data for the QC group
• Technical review of method transfer/verification protocols
• Technical writing of specification documents, standard test procedures, general test procedures, SOPs, qualification protocols
• Review, manage, and monitor stability trend tables
• Support investigations that arise in the QC testing of raw materials/finished products as needed
• Work with all parties as applicable, technical services, material management, manufacturing, packaging, and the laboratory to identify the breadth and scope of the investigation to determine the appropriate root cause
• Support the implementation of corrective actions, complete the trending analysis, and determine product disposition as applicable
• This role will foster a collaborative relationship with manufacturing and laboratory personnel, focusing on high-quality, systematic investigations, meaningful corrective actions, and reducing the rate of deviation generation. Provide support to determine appropriate corrective actions to prevent the recurrence of the deviation
• Track the effective measure of each implemented corrective action and take appropriate action if and when required
• Provides oversight and final review of investigations to ensure adherence to cGMP, rigorous technical content, investigation clarity, and completeness

Qualifications - Skills & Requirements

• B.S/MS degree in engineering/Chemistry/Scientific field required
• Minimum 3 years of experience in an analytical role, technical review role, or quality assurance role with an emphasis on raw data review within the pharmaceutical industry
• Familiarity with Empower 3 data collection system
• Working knowledge of cGMPs and regulatory requirements as they apply to pharmaceutical testing.
• Familiarity with compendial methods (USP/NF, EP, JP, BP, etc.)
• Experience in investigation/deviation management
• Technical writing skills with experience related to both laboratory and manufacturing investigations

Education & Experience

- B.S/MS degree in engineering/Chemistry/Scientific field Required
- Minimum 3 years experience in an analytical role, technical review role, or quality assurance role with an emphasis on raw data review within the pharmaceutical industry

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

Job requires the use of his/her feet to operate foot controls or for repetitive movementHand Manipulation is required - Fine Manipulation Left HandHand Manipulation is required - Fine Manipulation Right HandHand Manipulation is required - Simple Grasping Left HandLifting 8+ Hours - 0-10 PoundsHand Manipulation is required - Simple Grasping Right HandBending 1-4 HoursClimbing 1-4 HoursKneeling 1-4 HoursTwisting 1-4 HoursWalking 1-4 HoursSitting 5-8 Hours


Blood/Fluid Exposure Risk

Category II: Usual tasks do not involve exposure to blood, body fluid, or tissues but job may require performing unplanned Category I tasks.