Interview with Pharmaceutical Quality Assurance Officer
Given the complexities of jobs and the varying environment of the classroom and the work settings, many newly graduates who assume a job find the transition overwhelming. Regardless of the years of preparation and the theoretical formation, many still find themselves unprepared to take on the responsibility of a professional career. To respond to this growing concern, the academe has fostered the adaptation of a Professional Development Plan that would aid students in the gradual transition of their role from a student to a legitimate professional. In line with this endeavor, an interview to be conducted by the student with a professional currently working in the field was initiated. This interview was intended to aid the student in gathering important information and details related to their chosen career path. It was hoped that this preparation would help students feel more comfortable when transition into their new careers or, in the case where the student had inaccurate expectations regarding the roles, tasks and responsibilities applicable to their intended career, that it would help them change their career choice prior to leaving school.
- Nature of the Interview
The ultimate goal of this interview is to obtain information from an actual professional in the students intended field and to practice requesting information that will aid them in establishing foundation information, background, and professional details to prepare them for not just beginning a job, but the tasks involved in searching for a job as well. The student is required to explore the nature and details of the profession through a well- developed sequence of questions and follow-up questions, observation and documentation of non-verbal cues and behaviors, and through exploring any additional resources of contacts provided by the interviewee.
Information gathered included identifying the interviewee’s preparation before obtaining a job limited to educational background, training, skills and technical abilities. In addition, the interviewee was also questioned about her personal experiences related to the job such as her relationships with the company/company brand, coworkers, managers and other stakeholders of the organization. The challenges and barriers relating to the profession and professional advancement was also discussed. The interview took place after working hours at a coffee shop at the request of the interviewee due to the proprietary nature of the work being done at xxx Pharmaceuticals. As such no information related to the actual facilities was obtained or observed first hand, and instead was elicited from the interviewee.
- Relevant Background
This interview was conducted on October 14, 2014 with an employee of reputable Pharmaceutical Company in Philadelphia, PA. The individual asked to remain anonymous and in order to provide her with additional freedom to honestly answer questions posed, it was elected to grant anonymity. Thus, only the employee’s position and not her real name or other identifying information will be disclosed nor will identifying information about the pharmaceutical company itself be revealed.
The interviewee, who will be referred to as “Rose” in the course of this paper, is 38 years old, female, and has been working for the company for 5 years 2 months at the time this interview was conducted. She recently received excellent ratings on all areas of her five year evaluation. When asked if she would be willing to be interviewed she said yes adding she felt she had a good grasp of what the job entailed and the preparation necessary to obtain such a position.
- Organizational Profile: xxx Pharmaceutical
xxx Pharmaceutical states it’s goal is to consistently use only the most up to date innovations in order to help people feel better when they are experiencing pain. The company is geared towards offering new options for responsible and effective pain management. They have successful developed, tested, received approval for, and marketed three of the top ten over the counter pain relief medications and have two more currently undergoing FDA review. Among the current goals of the organization is to develop new drugs utilizing the SoluMatrix Fine Particle Technology to existing NSAID drugs while appropriating the lowest possible dose to manage pain. The company also develops prescription pain medications primarily for use after surgical procedures.
- Introductory Information
The employee was asked about her background preparation related to obtaining a job as quality control specialist at a pharmaceutical company.
4a. Education, Training, Previous Experience
The interviewee sated she had obtained a B.S. with a double major in Molecular Biology and Biochemistry, followed by a M.S. in Pharmaceutical Regulatory Affairs. Following her Master’s program she completed a one year paid internship in Pharmaceutical Quality Assurance and Regulatory She holds the position of Pharmaceutical Quality Assurance Specialist. She stated that the programs she attended were competitive and that, unlike some other positions, academic credentials are examined for all pharmaceutical related positions. She also stated that the field was becoming increasingly competitive and that while a Master’s degree and internships weren’t requirements for a job in this area, they increased the likelihood of being hired significantly. Also, with so much reliance on the internet today, she recommended training and experience in complementary areas such as Internet marketing. She stated given the increasing number of mergers that were occurring now, with downsizing always a looming threat, the more niche areas a new employee can fill the more likely they are to remain employed.
4b. Previous Experience
The interviewees experience prior to accepting her current position included working in Quality Assurance for two small-moderately sized pharmaceutical companies. While at these companies, the interviewee was responsible for reviewing all procedures to ensure they met State and Federal standards.
- Current Role, Organizational Climate and Information about a Career in the Field
The interviewee’s role involves in depth auditing of study data for specific drugs being developed. She explained that quality experts are responsible for making sure that all drugs are produced and investigated in compliance with federal standards. They examine the plants and labs where the drugs are manufactured and studied, including any partnering investigator sites, review all self- study data on drugs prior to requesting review by the FDA, regularly validate all manufacturing procedures and computer equipment, software and interfaces.
The interviewee stated that the organizational climate was moderate to high stress due to the need to ensure a rapid work flow pipeline in order not to expend further financial resources in a sector that was one of the most expensive to maintain. She stated that every position at the company supported the outcome of producing high profit margin, effective and salable medications and meeting all deadlines was a must. She also said that based on the other employees she’d met over the course of her career that she felt that people who went into the field were self-starters, enjoyed fast paced, high demand positions and were independent such that they didn’t require much oversight. However, when a drug received FDA approvable, (she said that only 1 in 5000 actually make it to market), all employees celebrated and received positive feedback and incentives from management.
- Challenges in the First 90 Days
The interviewing stated that a new hire had a difficult time in the first three months of a job with the company. She said that all new hires are placed on probabtion for the first 3 months and therefore, until they have successfully passed that time frame and are promoted to regular status few other employees took the time to get to know them or invite them out. Another reason for this she stated was that if there was some type of catastrophe that occurred (she sited several that had occurred at Johnson and Johnson’s and Merck) the management would need to hold some employees accountable and new employees were always vulnerable to this type of problem, along with any need to downsize or increase funds in one area by decreasing expenditures in another. She stated this didn’t happen often, but it did contribute to a sense of alienation at the beginning of the job. The reward, she stated, was when you succeeded in being promoted to regular status, you became a member of the team and were treated that way. In regards to the vulnerability involved in being a new employee, she said that was not specific to the Pharma sector and was regular policy throughout the various employment sectors. You just had to find ways to make yourself indispensable, through additional training and specialization in your own area on the one hand, and widening your skills base through training in outside, highly valued areas on the other.
