Quality Complaint Investigator (Administrative)

Description:

The Complaint Investigator, Quality is responsible for the execution of investigations, to determine root cause of complaint issues for all New York sites, investigation report writing and QUMAS entry and maintenance respective to Product Quality Complaints for products manufactured by or for Amneal Pharmaceuticals for the US market. The position is responsible for coordination of actions/tasks associated with retain inspections, and testing of samples evaluation of the customer returned sample for detects and root cause assessment and review production record (manufacturing and/or packaging). Other key responsibilities include, support to Pharmacovigilance group for of Adverse Events as needed, identification of adverse product or batch trends and keeping Quality management apprised in a timely manner to allow for FAR decisions as necessary. This position will interact with other department and operating groups (domestic and international) within the organization to include but not limit to,  Operations, Quality Control, Drug Safety, Pharmacovigilance, DEA and Quality Assurance and Quality Management.

Schedule:

1st Shift 8:00am - 4:30pm Monday to Friday 

Essential Functions:

• Execute technical investigations to address product quality complaints and creates thorough, comprehensive reports determining root cause of the complaint issue
• Conducts manufacturing and/or packaging batch record reviews in support of Product Quality Compliant investigations and ensures conformance to task timelines and maintains Caliber Assure-iq entry and attachment of supportive documentation
• Independently works in Caliber Assure-iq and coordinates tasks with QA, QC and Drug Safety in support of investigation actions as needed, and in accordance with timelines
• Evaluates returned complaint samples and utilizes findings to direct the course of the complaint investigation to determine root cause. Ensures that supportive documentation of inspection is uploaded into Caliber along with any supportive documentation. Initiates and/or performs retain visual inspections in support of product quality complaint investigations and ensures timeliness of completions and maintains Caliber Assure-iq entry and attachment of supportive documentation
• Interfaces with QC Lab and/or Contract Laboratories to arrange for complaint sample testing and provides samples. Advises laboratory of timelines for results, follow up, obtaining comprehensive reports and with Caliber Assure-iq interface to ensure results are included in the complaint record.
• Review of quality complaints and compilation of metrics on products, complaint issue and lot for evaluation and reporting to Quality Management.
• Performs manufacturing and/or packaging batch record reviews in support of Pharmacovigilance Adverse Events investigations
• Develops and defines appropriate CAPAs respective to correcting or preventing similar complaint occurrences.

Additional Responsibilities:

• Tracks investigation timelines and prepares extension memos when needed. Submits memo's into Caliber Assure-iq.
• Ensures timelines are met for investigation actions through follow up with colleagues, co-workers and/or contract service providers as needed
• Supports Amneal India of US marketed products with performance of quality complaint returned sample inspections and submission to QC lab for testing when and as needed
• Identifies adverse product or complaint trends through historical reviews and metric generation as needed, and informs management of repeated complaint types, categories or product lots
• Directly handle or be in the close proximity with controlled drugs. Handling and exposure would be maintained under controlled /restricted conditions, within a secured area and will be required to maintain conformance with DEA and Amneal procedures at all times
• Assist Complaint Manager with task assignment and complaint closure activities in Caliber Assure-iq.

 

Education:

• Associate Degree or Science or related field plus 4 year exp in Pharma - Required
• Bachelors Degree (BA/BS) Science or related field - Preferred

Experience:

• 2 years or more in 2+ years experience in Pharmaceutical or Related Industry experience with BS (or 4+ years with an AA)
• 2 years or more in 2+ years experience in Medical Device Industry experience in quality assurance or customer service role
• 1 year or more in 1 year or more experience in an investigative (complaint or deviation) role

Skills:

• Works independently with minimal supervision in an investigational setting - Intermediate
• Strong Writing and verbal skills, English proficiency - Advanced
• Strong Interpersonal skills and works well with others - Beginner
• Pharmaceutical, Medical Device or related industry customer service or quality complaint handling - Intermediate
• cGMP and computer skills (MS Word, Access and Excel) - Intermediate
• Multitasking and flexibility to accommodate changing priorities. - Advanced
• Strong organizational skills to handling multiple open tasks - Intermediate

Specialized Knowledge:

• Previous experience with a EDMS system, e.g. QUMAS or Trackwise would be optimal
• Pharmaceutical, Medical Device or related industry customer complaint handling or investigation report writing

The base salary for this position ranges from $72,000 to $85,000 per year.   Amneal ranges reflect the Company's good faith estimate of base salary that Amneal reasonably believes that it will pay for said position at the time of the posting.  Individual compensation will ultimately be determined based on a variety of relevant factors, including but not limited to, qualifications, geographic location and other relevant skills.  At the heart of our Total Rewards commitment is a comprehensive, flexible and competitive benefits program for eligible positions that enables you to choose the plans and coverage that meet your personal needs. This includes above-market, diverse and robust health and insurance benefits to meet the varied needs of our employees as well as a significant 401(k) matching contribution to help our employees save for retirement.  We also promote employee well-being with programs that helps you enjoy your career alongside life's many other commitments and opportunities.

 

Amneal is an Equal Opportunity Employer that does not discriminate on the basis of sex, age, race, color, creed, religion, national origin, sexual orientation, gender identity, genetic information, disability, veteran status, liability for service in the U.S. Armed Forces or any other characteristic protected by applicable federal, state, or local laws.