1+ months

Investigation Writer II

Kelly Services
Barceloneta, PR 00617
Job Description

Responsible of performing Exception Reports, Complaints, PQRs and Trend Monitoring systems, assuring they are in compliance with Customer Site Operations policies, APL procedures and regulatory regulations and requirements.

Primary Quality liaison between site quality and other areas of a plant operation such as MS&T, Supply Chain, Operations, Incoming Quality, Engineering, Third Party Manufacturers (TPM),Third Party Contractors(TPC), etc.

Responsible of performing investigation activities when an exception event occurs in the manufacturing, incoming lab, validation, microbiology, stability, or complaints area.

a. Responsible for consistent and thorough exception events investigation, documentation and timely resolution of exception documents based on CAPA requirements.

b. Responsible of monitoring and continuous improvements of the CAPA quality system.

c. Compile the information and write the exception documents for multiple approvals.

d. Assure that exception documents are written according Operations policies, APL procedures and regulatory requirements.

e. Manage the exception event investigation process to assure all aspects of the exception event are investigated and root cause is determined.

f. Asses product impact, conduct through analysis and make informed and accurate recommendations of the implication of the exception event.

g. Determine appropriate corrective actions intended to correct the situation and prevent reoccurrence.

h. Assure exception events reports are approved on time as required by Customer polices and regulatory requirements.

i. Assure al CAPAs determined through the investigation process are implemented on time in compliance with Customer policies and regulatory requirements.

j. Assess CAPAs effectiveness in compliance with Customer policies and regulatory requirements.

Responsible of performing complaints investigations when product quality complaints are received at the plant and assuring they are in compliance with Customer Operations policies, APL procedures and regulatory requirements.

a. Assure complaint investigations are performed in a timely manner and appropriate actions are taken to protect the company and customer interests.

b. Implement any required CAPA.

Responsible of providing support to the plant users on the Exception Events IT System.

Responsible of maintaining the Product Quality Reviews (PQRs) system in compliance with Customer policies, plant procedures and regulatory requirements.

a. Generate the PQRs for each product list number manufactured at APL on a timely manner and assuring they are in compliance with regulatory regulations and requirements.

b. Prepare and approve PQR schedule as required assuring all APL products are included.

c. Perform statistical analysis and generate Trend Reports for each product requirement to be included in the PQR, as required.

d. Evaluate product performance based on the data collected for the PQR generation, such as change control, exception events, analytical, in process tests, stability, validation, regulatory, recalls, etc.

e. Determine any adverse trend or pattern that could lead to the change in specifications, manufacturing or control procedures.

Perform Track and Trend of investigations to identify quality issues trend and perform monthly investigations metrics.

Perform periodic quality metrics related to investigations, complaints, PQRs and other key performance indicators from areas of responsibility as requested by area managements.

Responsible of providing NPI support as a QA investigator writer as required by the NPI process and serve as a QA liaison between APL and Third Party Manufacturers or Third Party contractors.

Responsible of providing support during internal or external inspections.

Responsible for executing assigned tasks as required by the operational area.

Conform to EH&S management system requirements, promote continuous improvement, and consider EH&S aspects during the design and change process.


Bachelor degree, preferably in Engineering or Science.

**Experience Required:**

Five (5) years of experience within the Pharmaceutical Operations, preferably solid dose manufacturing process.

Effective verbal and written communication skills in both English and Spanish.

Candidates MUST have experience in Manufacturing Process and Investigations

Solid Dose Manufacturing experience

CAPA full acknowledge and experience

**You should know:** Your safety matters! Vaccination against COVID-19 may be a requirement for this job in compliance with current client and governmental policies. A Kelly recruiter will confirm and share more details with you during the interview process.

**Why Kelly** **** **?**

Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire talented people just like you. Every day, we match science professionals with dream jobs that fit their skills and interestsits the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background/education in science, so we know a thing or two about the science market and how to get you noticed.

**About Kelly** ****

At Kelly, were always thinking about whats next and advising job seekers on new ways of working to reach their full potential. In fact, were a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live (plus, did we mention we provide a ton of benefits ?). Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.

Kelly is an equal opportunity employer committed to employing a diverse workforce, including, but not limited to, minorities, females, individuals with disabilities, protected veterans, sexual orientation, gender identity. Equal Employment Opportunity is The Law. (


Posted: 2022-04-15 Expires: 2022-06-16

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Investigation Writer II

Kelly Services
Barceloneta, PR 00617

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