Supervisor II, Quality Assurance (OSD) (3rd shift)

AbbVie; Barceloneta (PR); On-site; USD 70,000 - 90,000; Full time

Benefits offered by this job

Paid time off

Medical/dental/vision insurance

401(k)

Short-term incentive programs

Job summary

AbbVie in the United States and Puerto Rico region seeks a Quality Assurance Supervisor II to oversee QA staff on the manufacturing floor, ensure product quality and regulatory compliance, and drive continuous improvement initiatives to meet business goals.

The role requires a Bachelor's degree in sciences or engineering, 2+ years of supervisory experience in a regulated pharmaceutical setting, and strong problem-solving and cross-functional collaboration skills.

Qualifications

• Bachelor's degree in sciences or engineering is required.
• 2+ years of experience supervising a team in manufacturing.
• Experience in regulated pharmaceutical environments and FDA/GMP knowledge.
• Strong problem-solving, decision-making, teamwork and conflict resolution.
• Ability to work cross-functionally and lead improvements.

Responsibilities

• Lead a Quality function team, hire, set performance expectations and provide feedback.
• Provide QA support on the manufacturing shop floor and ensure production schedules.
• Document exceptions and drive corrective actions with Operations.
• Review and approve procedures and change requests; support continuous improvement.
• Back up the Quality Manager as needed and ensure GMP compliance.

Skills

Team leadership

GMP knowledge

Problem solving

Regulatory awareness

Cross-functional collaboration

Education

Bachelor's degree in sciences or engineering

Tools

GMP systems

Job 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.

Company Description

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

The Quality Assurance Supervisor II is responsible for the organization, administration, and supervision of Quality Assurance employees within the manufacturing operations. Responsible for properly overseeing the day-to-day operations by prioritizing shop floor presence. This includes delivering high levels of customer service, ensure quality of product and services, comply with all regulatory requirements, achieve desired financial performance including cost reductions, and build a culture of high performance for the team. Ensures that appropriate controls are developed and maintained for new, intermediate and finished products. Responsible for GMP compliance, manufacturing quality, product control and release, system execution and quality planning for the manufacturing areas that it supports. The Quality Assurance Supervisor II is expected to work independently and serve as a mentor to other supervisors.

Responsibilities

• Leads a team in the Quality function and is responsible for hiring, setting performance expectations, driving team engagement, providing continuous and on-time performance feedback, developing staff, assisting team in problem-solving, and handling of employee matters. Ensures that the department has the appropriate talent and level of performance to meet business objectives. Monitors administration of training, identifies training needs, and development of team.
• Provide Quality support on the manufacturing shop floor
• Responsible for supporting Operations efforts in meeting established production schedule
• Partner with Operations employees to document exception documents, including re-inspection and resolve other outstanding plant quality/compliance issues
• Propose changes update, author, and implement departmental procedures consistent with objectives of simplification and process efficiencies/improvements which ensure ongoing compliance
• Investigate QC hold, quarantine and reject for materials not meeting standards, ensure the initiation of exception documentation and oversee the implementation of any corrective action
• Responsible for the review and approval of Procedures and Change Requests
• Assist/serve/provide feedback on continuous improvement initiatives/teams
• Reviews and releases batch records May serve as a backup when the Quality Manager is unavailable. Performs other tasks/projects as assigned.

Qualifications

• Bachelor's degree in sciences or engineering required.
• 2+ years of experience supervising a team and at least 2 years of experience in a manufacturing production environment.
• Experience in regulated pharmaceutical industry .
• Thorough knowledge of Quality Assurance operations with multiple years of experience in safety, application of FDA and GMP regulations.
• Direct manufacturing and regulatory interface experience is preferred.
• Effective problem-solving, decision-making, teamwork, influence, negotiation, and conflict resolution skills required
• Ability to work cross-functionally and coordinate work both within the department and with other departments.
• Ability to identify, communicate, and follow through to completion and assist in the development of necessary corrective action plans to resolve problems with supervision
• Demonstrated strong leadership skills and ability to foster an inclusive environment
• The candidate must have availability to work on a 3rd shift (Monday to Friday, 9:00 p.m. - 6:00 a.m.; and alternate weekends)

Additional Information

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

• 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.

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.

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