Senior Writer, Investigation - Barceloneta, Puerto Rico - AbbVie

Descripción

The Senior Investigator Writer is responsible for providing quality assurance support for the plant including resolution corrective and preventive action for events, leading and participating in investigations, coordination and leading of local Change Plan, support in complaint investigations, quality improvement programs, and assurance of cGMP and AbbVie policy compliance for the manufacturing plant.
Understands internal business process, to make appropriate prioritization of their assigned work duties.

Responsibilities

• Perform exception reports, complaints, PQRs, CP coordination and trend monitoring systems, assuring they are in compliance with AbbVie Operations policies, plant procedures and regulations.
• Investigate activities when an exception event occurs in the manufacturing, incoming laboratory, Quality Control laboratory, validation, microbiology, stability or complaints area.
• Responsible for consistent and thorough exception events investigation, documentation and timely resolution of exception documents based on CAPA requirements.
• Perform complaint investigations when product quality complaints are received at the plant and assuring, they are in compliance with AbbVie Operations policies, plant procedures and regulatory requirements.
• Perform laboratory investigations when out of specification or trend results are reported in accordance with AbbVie procedures and policies.
• Provide support to the plant users on the Expectation Events IT Systems.
  Document and coordinate Local change plans assessment and strategies in support with the end user and functional impacted areas.
• Perform periodic quality metrics related to investigations, complaints, CP, PQRs and other key performance indicators from areas of responsibility as requested by area managements. Responsible of providing New Product support as a QA investigator writer as required by the New Product process and serve as a QA liaison between AbbVie, Ltd. 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. Could be assigned the responsibility of evaluating potential events, as first point of contact, in the manufacturing floor, to define immediate mitigation activities.
  Conform to EHS management system requirements and compliance obligations, promote continuous improvement, and consider EH&S aspects during the design and change process. Comply with all EHS procedures and policies including incident reporting, use of PPE, waste management and disposal, and any other program applicable according to the position duties.

Significant work activities:

• Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hr day) is required
• Continuous standing for prolonged periods (more than 2 consecutive hours in an 8 hr day) is required
• Continuous walking for prolonged periods (more than 2 consecutive hours in an 8 hr day) is required
• Frequent to continuous computer usage (greater or equal to 50% of the workday) is required

• Bachelors Degree in Science or Engineering, preferably Biology or Chemistry with a minimum of four (4) years of experience in a Quality or technical field within the Pharmaceutical or Biotechnological industry.
• Masters Degree in Science or Engineering, preferably Biology or Chemistry with a minimum of two (2) years of experience in a Quality or technical field within the Pharmaceutical or Biotechnological industry.
  Advance knowledge and prior exposure in technical and operations necessary to successfully perform responsibilities of position. Knowledge of GMP, safety regulations.
• Effective verbal and written communication skills in both English and Spanish.
• Prior experience in CAPA, including authoring and approval of laboratory and manufacturing investigations. Experience in other quality system (example: Change management, risk management documentation) is desired.
• Strong interpersonal and communication skills.
• Strong problem solving skills.
• Capable of handling multiple priorities.

Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law: ​

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• The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location, and we may ultimately pay more or less than the posted range. This range may be modified in the future.​
• We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees.​
• This job is eligible to participate in our short-term incentive programs. ​

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Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole and absolute discretion unless and until paid and may be modified at the Company's sole and absolute discretion, consistent with applicable law. ​

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AbbVie is committed to operating with integrity, driving innovation, transforming lives, serving our community and embracing diversity and inclusion. It is AbbVie's policy to employ qualified persons of the greatest ability without discrimination against any employee or applicant for employment because of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information, gender identity or expression, sexual orientation, marital status, status as a protected veteran, or any other legally protected group status.