Author Archives: P Yeatman
Question Regarding Making Cephalosporin and Cytotoxic Drugs in the Same Building
The Question posed on LinkedIn:
“Dear Experts: Is it possible to make Cephalosporin and Cytotoxic drug in a same building considering Risk Assessment ?“
Book Review of “Eliminating the Gobbledygook” by Kathy Walsh
As one with a love for documentation and trying to communicate effectively and concisely, I bought a copy of Eliminating the Gobbledygook – Secrets to Writing Plain Language Procedures by Kathy Walsh. I am pretty sure I worked alongside Kathy some years back on what was called the Documentation Effectiveness Project at Mayne so I was not expecting too many surprises as we both know our stuff. The purpose of the book purchase was to refresh and update my knowledge of controlled document writing. I figured I may as well review the book in the process. Continue reading
About 20% of (FDA) Recalls are Due to Microbial Contamination.
As of March 4 2020, 16 of the last 50 recalls by the FDA for pharmaceutical products were due to microbial contamination or a lack of sterility assurance. Another 27 were due to impurities with 5 more due to mislabeling. Looking at TGA recalls for 2019, around half of the medicine recalls due to contamination were the result of microbial contamination. Continue reading
The Generic Resume
As part of my job search, I tailor my resume and cover letter to match the requirements of the role being applied for.
An efficient way to do this is to have everything present in the source documents and then trim it down for the role.
Here is an iteration of my resume before tailoring. I do something similar for my cover letters. The important thing here once you have tailored your documents, let them sit for a day. That allows you (or at least me) to pick up on any errors and give the doccos a fresh proof read.
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Interview Questions I Have Asked
Often there had been sufficient two way dialogue to negate the need to ask questions at the end of an interview. A lots of advice says not asking questions as the end of an interview is a cardinal sin. If the rapport had been good, the IMO there is no point. What I’ll do is state that everything was covering during our exchange and perhaps summarize a thing or two.
- What are the major responsibilities for this position?
- Are there any changes expected in the responsibilities of this job?
- What organizational changes do you anticipate?
- What personal qualities would you expect the successful candidate to possess?
- What are the greatest challenges facing the person in this position?
- What are prospects of future growth and expansion of the company/organization? Are there opportunities for advancement within
the organization? - What new products/services is your organization thinking of implementing?
- Why is this position open?
- Who would I be interacting with the most in this position?
- How does this position fit in with the structure of the organization?
- Do you have an employee training program?
- When can I expect to know your decision?
- How many other applicants are being interviewed at this stage
- What is my expected remuneration? (Wages or salary)
- When will decision be made and is there more than one interview
- If I am replacing an staff member, will they be present to mentor or train me initially?
- Is my requirement to give my current employer 4 weeks notice an issue?
- I would like to confirm the hours. I imagine some flexibility would be required if needed.
- Is there anything about me in this interview you have concerns about regarding my suitability for this role?
- If I am offered the role and accept, how will you determine if I was a successful hire in 6 months time?
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What is Data Trending and How To Identify, Action and Report Trends
The following is an article I placed on LinkedIn and was written as part of my Developing My Writing While Helping Others series.
Paul Yeatman is a microbiologist with over 15 years’ experience in documentation, validation and running investigations in TGA and FDA regulated environments. He has a strong interest in process improvement, documentation, training and developing others. From 9-5 Paul investigates and solves software problems. By night he works on his science chops. He has an arty streak, runs several blogs and enjoys communicating his experiences and knowledge in arenas such as this. Continue reading
Question regarding Bacillus subtilis recovery when testing for absence of Salmonella sp.
The Question posed on LinkedIn:
“Dear experts, During microbial contamination testing for specific organisms – salmonella growing was observed. identification shows that is not Salmonella, but Bacillus subtilis. How i shoud interprated the results, pass specification or not?“
Question regarding sterile filter hold time validation
The Question posed on LinkedIn:
“How to validate maximum hold time for product sterile filter after autoclave sterilization? Any link to regulatory guidelines is much appreciated.“
Interview Questions Asked of Me
The recommendation is to answer these questions using the STAR format.
- Situation: Describe the situation pertaining to the topic of discussion or the interviewer’s query.
- Technique: Explain the technique you used, your approach.
- Action: Emphasize the action you took to solve the situation.
- Result: Close with the result or outcome of the action taken.
I prefer the CAR format as it is pretty much the same, but IMO, more efficient.
- Context: What situation were you in? What background information does the listener need to understand the context? What was the task you were expected to perform? What needed to be done? What challenges did you expect to face?
- Action: What actions did you take? (You can also outline what alternatives you considered.)
- Result: What impact did your actions have? (These do not have to be all puppies and rainbows. You can admit that you got it wrong on the first try and had to go back and fix something.)
What follows are questions I have been asked during interviews
- Tell me about yourself, your background.
- Where do you see yourself in five years? Ten years?
- What are your career goals?
- Give us a brief rundown on your qualifications and employment history
- What are you qualifications for the position?
- What can you bring to this position?
- What are your strengths and weaknesses?
- What are your greatest accomplishments?
- What qualifications do you have that make you think that you will be
successful in your field? - What did you like best/least about your other jobs?
- What gives you personal satisfaction?
- Delegated a project or job effectively
- Adapted to a new and difficult situation
- Had to make an unpopular decision
- Handled a difficult situation with a co-worker
- Made a bad decision / mistake
- Worked effectively under pressure
- Provide an example of when you have been responsible for or driven change
- Describe your ideal job
- Describe your ideal manager
- What qualities should a successful manager possess?
- Describe the best supervisor you’ve ever had
- What do you consider to be your greatest strengths and weaknesses?
- How would a good friend describe you?
- Do you prefer independence or a team structure?
- What kind of supervision do you prefer? What qualities in a supervisor do
you like most? - How do you handle instructions and criticism?
- Are you willing to relocate for the job?
- What do you know about us?
- Why do you want to work for us?
- How can you make a contribution to our organization?
- What job in our organization would you choose if you were entirely free
to do so? - What interests you about our product or service?
- Why are you applying for this job?
- What is your understanding of the nature of the job and the company?
- How do you determine or evaluate success?
- Do you consider yourself a leader?
- What are the attributes of a good leader?
- Describe the workload in your current (or most recent) job.
- Describe what you do in a day (Tell us about your previous supervisory experience. What does it involve?)
- Which is more important: creativity or efficiency? Why?
- What two or three accomplishments have given you the most satisfaction? Why?
- When have you felt proud of an accomplishment at work?
- When have you made a positive contribution in your job?
- How do you work under pressure?
- What do you enjoy most about supervising?
- What do you enjoy least about supervising?
- What’s one of the hardest decisions you’ve ever had to make?
- What is the hardest decision you have had to make / thing you had to do as a supervisor?
- Tell us about your decision making skills
- Tell us about your problem solving skills
- What have you accomplished that shows your initiative?
- How do you motivate others?
- What would you do to establish your authority in this this position with your peers?
- What would you do to establish your authority within our facility?
- Tell us about how you meet deadlines. How do you deal with unreasonable deadlines
- How have you dealt with a difficult manager or team member?
- How would you deal with a poorly performing team?
- How would you deal with a poorly performing team member?
- What Evidence of resolving conflicts do you have?
- Detail situations that required you to use your negotiation skills
- How do you motivate employees, including those you are not directly responsible for?
- How have you dealt with a major problem?
- Talk us through your experience working with testing samples in a lab and quality testing?
- Talk us through your recent Manufacturing or Quality technician experience that is relevant to this role?
- What motivated you to apply for this role?
- What techniques do you use to manage time / people?
- How do you exchange information within your team / with customers / with other departments?
- What were your achievements in you last/current position (or place of employment)?
- Why are you best suited to this position? / Why should we employ you in this position? / What in your background indicates you’re prepared for this position?
- Tell me a time where you made a mistake. What happened, how did you react, and what was the result?
- Tell us about a situation where you made a decision you later regretted / would make a different decision.
- What have you learned from your mistakes?
- When have your technical skills been challenged?
- When have your supervisory skills been challenged?
- Once an issue has been identified, how did you resolve it and ensure that it did not occur again?
- What makes you think you would be suited for a quality assurance associate role?
- What have you done to prepare yourself for a quality assurance associate role?
- Tell us about Good Manufacturing Process
- What in your own words, defines quality / is quality?
- What are the 3 changes you would implement immediately / (if currently working at company where interview is) What has prevented you from making these changes already?
- What do you know about <company you are interviewing for>
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