This is a hybrid role, with 3x days on-site in Hawthorne, NY

The position of Quality Assurance Associate is responsible for execution of the day-to-day operational activities of Quality Assurance (QA) department for In-Market Quality. Knowledge and experience are required across wide range of QA responsibilities including product quality complaint investigations, deviation and CAPA investigations, In Market Label Artwork Review, SOP Document Management, Batch Release and product disposition, Product Reworks, audit program, annual product reviews, contract service provider oversight and issue resolution, GMP Training, Technical Quality Agreements. This role is responsible for assigned activities to assure internal compliance and Taro marketed products meet applicable regulatory requirements. All work needs to be accomplished in accordance with GMP requirements. This role is responsible for an effective support and continuous process improvement; manages and promotes the culture of quality and compliance.

Duties and responsibilities

• Execute finished product releases and approval of the Work Orders; review Certificates of Analysis and Certificates of Manufacture to provide final disposition of all products.
• Ensure execution of the Full Batch Release Program.
• Review the product quality complaint investigations conducted by internal and Contract Service Providers; review and documents investigations in Product Quality Complaint records.
• Provide quarterly trending of Product Quality Complaints to management and other departments as necessary. Review trending information and investigate as necessary to improve customer experience and quality of products.
• Assess Quality Events that occur during holding/warehousing of the products; initiate and manage deviations and CAPAs to completion.
• Ensure Fulfillment and Rework Centers are audited on a timely basis, in alignment with Taro procedure(s).
• Approve Annual Product Reviews to verify consistency of the process, assess trends, and determine if there is a need for changes in specifications, production, manufacturing, and/or control procedures.
• Execute completion of the Post-Marketing Surveillance chapter of the Annual Product Review Reports.
• Responsible for maintenance, documentation, approval and control of Technical Quality Agreements/Quality Assurance with Fulfillment and Rework Centers.
• Maintain SOP Document Management, to ensure that relevant and understandable written procedures are available to the TPC organization as well as TPC suppliers.
• Compile data and metrics of quality systems for Quality Management Review.
• Revise finished good rework instructions received from Supply Chain, to ensure compliance and guarantee quality product. Distribute revised and approved rework instructions to applicable rework center(s).
• Review and approve artwork to ensure cGMP requirements are met.
• Review and approve warehouse temperature monitoring logs, to have an understanding of temperature levels throughout warehouses.
• Review transportation documents to ensure truck setting in compliance with USP 1079.
• Ensure applicable reports pertaining to Product Quality Complaints records, containing applicable data, are sent to appropriate individuals.
• Participate in multifunctional project teams to support introduction of new products and/or changes to current products; to ensure compliance with Quality System requirements.
• Perform other duties as assigned & providing overtime as needed.

Qualifications

• Minimum of B.Sc. Chemistry or other associated field
• Minimum 5 years’ experience in Quality Assurance or Quality Control in the pharmaceutical or related industry environment
• Experience in support of communications with Regulatory agencies officials such as USFDA
• Excellent knowledge of FDA  guidelines and regulations
• Capable of leading by influence in matrix environment
• Strong focus on flexibility, ability to multi-task, attention to detail, excellent organizational skills, good follow-up, excellent communication and writing skills
• Experience in Quality electronic systems such as SAP and Trackwise is an asset

Working conditions

• Non-routine and complex problems
• Dealing interdepartmentally/across sites to attempt to obtain facts in a rapidly changing atmosphere
• Ability to work under stressful conditions and prioritize workload
• Numerous and varied responsibilities demanding attention and detail

The presently-anticipated base compensation pay range for this position is $68,500 to $84,000. Actual base compensation may vary based on a number of factors, including but not limited to geographical location and experience. In addition, this position is part of the Annual Performance Bonus Plan. Employees are eligible to participate in Company employee benefit programs which include medical, dental and vision coverage; life insurance; disability insurance; 401(k) savings plan; flexible spending accounts; and the employee assistance program. Employees also receive various paid time off benefits, including vacation time and sick time.

The compensation and benefits described above are subject to the terms and conditions of any governing plans, policies, practices, agreements, or other materials or documents as in effect from time to time, including but not limited to terms and conditions regarding eligibility. If hired, employee will be in an “at-will position” and the Company reserves the right to modify base salary (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company, or individual department/team performance, and market factors.

The preceding job 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 as assigned to this job. Nothing herein shall preclude the employer from changing these duties from time to time and assigning comparable duties or other duties commensurate with the experience and background of the incumbent(s).

We provide equal employment opportunities for all current employees and applicants for employment. This policy means that no one will be discriminated against because of race, religion, creed, color, national origin, nationality, citizenship, ancestry, sex, age, marital status, physical or mental disability, affectional or sexual orientation, military or veteran status, generic predisposing characteristics or any other basis prohibited by law.

Notice to Agency and Search Firm Representatives:

Taro Pharmacueticals is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Taro employee by a third party agency and/or search firm without a valid written & signed search agreement, will become the sole property of Taro. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral.