Manufacturing Technician (Documentation Support)
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What you'll do
- Carry out daily tasks as assigned by the Senior Operations Manager according to GMP and the quality system.
- Active involvement and management of batch related CAPA’s as they arise in the business unit taking them from the initial review state through RCA, approval, batch disposition and delivery of corrective and preventive actions, liaising closely with the relevant Departments to ensure thorough investigation is completed and timely resolution and closure is met.
- Assist in the management and closure of existing CAPA’s through the evaluation of the current status of corrective and preventive action including interdepartmental co-ordination to ensure robust actions are in place to prevent reoccurrence prior to closure.
- Lead and support continuous improvement initiatives as required to support the overall goals of the Biologics 2 Process Team.
- Based on knowledge and previous experience you will also be requested to facilitate, support and generate RCA reports.
- Participate in GEMBA’s and Process Confirmations in an effort to identify further improvement opportunities within the department.
- Manage requirements in order to deliver the KPIs as they relate to the Product Flow function with specific emphasis on the batch release cycle.
- Carry out daily tasks as assigned by the Manager according to GMP and the quality system.
- Participating in root cause analysis and problem-solving.
- Completing compliant investigations and environmental excursions.
- Adhering to all company standards in safety, housekeeping and quality, notifying management of any discrepancies.
- Follow gowning procedures on entry to areas.
What they're looking for
- Leaving cert or equivalent qualification required.
- Understanding of the requirements to work in a regulated GMP industry.
- Ability to build strong relationships and work within cross-functional teams.
- Adaptability to work in a fast, dynamic environment whilst adjusting readily to meet unexpected constraints.
- Drive, high energy, maturity, and ability to work under pressure, deliver results, and overcome obstacles.
- Team player who can collaborate with others to achieve organizational targets and goals.
- Excellent communication skills.
Nice to have
- Third Level qualification in science or engineering discipline is an advantage but not essential.
- Knowledge of biologics operations an advantage.
Summarised by NextRaise from the employer’s description, which follows in full below.
Full description from employer
Company Description
About AbbVie
AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on LinkedIn, Facebook, Instagram, X and YouTube.
Job Description
Welcome to AbbVie!
Our employees work every day to discover and address many of the world's most pressing health challenges. When you have patients depending on your solutions, you look for the best people to join the team.
We are excited to invite experienced and driven candidates to apply to our Manufacturing Technician (Documentation Support) opportunity here at AbbVie Westport. In your new role as Manufacturing Technician (Documentation Support) you will ensure the continued success of our Biologics 2 business unit by taking ownership of various duties relating to CAPA and continuous improvement, documenting batch related activities, housekeeping and aseptic manufacturing. You will also have the opportunity to work with the latest industry tech and develop your skillset by joining a talented and high performing group.
Key Responsibilities:
- Carry out daily tasks as assigned by the Senior Operations Manager according to GMP and the quality system.
- Active involvement and management of batch related CAPA’s as they arise in the business unit taking them from the initial review state through RCA, approval, batch disposition and delivery of corrective and preventive actions, liaising closely with the relevant Departments to ensure thorough investigation is completed and timely resolution and closure is met.
- Assist in the management and closure of existing CAPA’s through the evaluation of the current status of corrective and preventive action including interdepartmental co-ordination to ensure robust actions are in place to prevent reoccurrence prior to closure.
- Lead and support continuous improvement initiatives as required to support the overall goals of the Biologics 2 Process Team.
- Based on knowledge and previous experience you will also be requested to facilitate, support and generate RCA reports.
- Participate in GEMBA’s and Process Confirmations in an effort to identify further improvement opportunities within the department.
- Manage requirements in order to deliver the KPIs as they relate to the Product Flow function with specific emphasis on the batch release cycle.
- Carry out daily tasks as assigned by the Manager according to GMP and the quality system.
- Participating in root cause analysis and problem-solving.
- Completing compliant investigations and environmental excursions.
- Adhering to all company standards in safety, housekeeping and quality, notifying management of any discrepancies.
- Follow gowning procedures on entry to areas.
- Adhere to and support all EH&S standards, procedures, and policies.
Qualifications
- Leaving cert or equivalent qualification required.
- Third Level qualification in science or engineering discipline is an advantage but not essential.
- Understanding of the requirements to work in a regulated GMP industry.
- Ability to build strong relationships and work within cross-functional teams.
- Adaptability to work in a fast, dynamic environment whilst adjusting readily to meet unexpected constraints.
- Drive, high energy, maturity, and ability to work under pressure, deliver results, and overcome obstacles.
- Team player who can collaborate with others to achieve organizational targets and goals.
- Knowledge of biologics operations an advantage.
- Excellent communication skills.
Additional Information
AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled.
US & Puerto Rico only - to learn more, visit https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html
US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:
https://www.abbvie.com/join-us/reasonable-accommodations.html
Company
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