Supervisor, Documentation , Tissue Services (Onsite)

Initial Therapeutics, Inc.; Branchburg Township (NJ); On-site; USD 60,000 - 100,000; Full time

Job summary

Join a forward-thinking company dedicated to innovative healthcare solutions. This role involves supervising a dynamic team, ensuring compliance with regulatory standards, and fostering a collaborative environment. You will lead the donor release process, manage performance, and drive quality improvements while supporting your team's professional growth. This position offers a unique opportunity to make a significant impact in the healthcare sector, contributing to life-changing therapies. If you are passionate about quality and leadership in a regulated environment, this is the perfect opportunity for you.

Benefits

Paid time off

Medical insurance

Dental insurance

Vision insurance

401(k) plan

Short-term incentive programs

Qualifications

• 3-5 years of experience in a GMP environment required.
• AATB Certification preferred.
• Ability to work varied schedules including weekends.

Responsibilities

• Supervise donor release process ensuring compliance with SOPs.
• Train and develop team members to meet business objectives.
• Manage activities to meet monthly release targets.

Skills

Advanced computer skills

Current Good Manufacturing Practices (cGMPs)

Quality systems understanding

Statistical techniques knowledge

Detail-oriented

Problem-solving skills

Soft skills for communication

Organizational abilities

Education

Bachelor's degree or equivalent

Tools

SAP

Oracle ERP

Microsoft Office Suite

Job description

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: immunology, oncology, neuroscience, and eye care, as well as products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on X, Facebook, Instagram, YouTube, LinkedIn, and Tik Tok.

Job Description

Supervise a team and is responsible for hiring, leading, and developing team members to ensure the department has the appropriate talent and level of performance to meet business objectives. This position is also responsible for assuring donor information is complete, accurate, and reviewed to assure donor release requirements adhere to applicable regulatory requirements. They will be responsible for, but not limited to, organizing communications with TRPs, performing donor chart review, donor rejections and testing failures including any ERP system transactions required. They will play a key role in the training of personnel within the department.

Responsibilities:

• Supervise the activities associated with the donor release process and ensure it conforms with Standard Operating Procedures (SOPs) and all applicable state and federal standards and FDA and AATB regulations.
• Communicate with management on a routine basis and escalate issues as needed. Supervise the team by example, build relationships, and collaborate with internal and external customers.
• Manage the activities required to meet the monthly release target.
• Train, develop, motivate, and coach the team.
• Ensure adequate resources/staff to maintain business continuity, assigning work, meeting deadlines, interpreting, and ensuring compliance with organizational policies.
• Communicate and/or facilitate personnel actions, including but not limited to hiring, termination, salary and performance reviews, disciplinary action, approving paid time off, and approving overtime.
• Provide supervision, coaching and guidance, monitoring of activities, required problem resolutions, and projects. Create and sustain a positive team environment.
• Initiate, investigate, review, and/or partner in the identification of discrepancies and issue resolution for Nonconformances, CAPAs, and other quality records as applicable. Initiate IT tickets and Facilities tickets, and Equipment Work Requests (EWRs). Assist with corrective actions in cross-functional teams to mitigate recurrence of similar issues.
• Initiate, assess, coordinate implementation plans, and/or drive ECOs for processes related to donor release. Provide input and support for other change controls related to the Tissue Services process.
• Track and monitor Key Process Indicators (KPIs), implementing initiatives to increase departmental and cross-functional awareness and process improvements.
• Perform donor reviews, releases, and any other activities as needed.
• Ensure Tissue Services documentation is accurate and compliant.
• Perform applicable ERP training, transactions, transfer, status changes, and other activities as needed.
• Initiate and follow through on the change control processes.
• Be an active member in other cross-functional collaborative efforts and attend huddles, team meetings, and project meetings.
• Support 5S methodology and ensure the area is a safe and effective working environment.

Qualifications

• Bachelor's degree or equivalent preferred.
• 3-5 years of experience in a GMP environment performing related duties as listed in Key Duties & Responsibilities.
• Ability to work a varied schedule with some potential weekend, early morning, or late evening hours, if needed.
• AATB Certification preferred.
• SAP Knowledge.

Essential Skills:

• Advanced computer skills; high knowledge and understanding of Windows-based computer systems such as Microsoft Office Suite.
• Experience with Current Good Manufacturing Practices (cGMPs) and working in a regulated industry; familiarity with AATB, FDA, and/or USP regulations and guidelines.
• Experience with Enterprise Resource Planning (ERP) software, such as Oracle or SAP.
• Strong understanding of quality systems.
• Basic knowledge of statistical techniques and quality tools.
• Detail-oriented and self-motivated.
• Ability to carry out detailed written or oral instructions.
• Ability to work and communicate (soft skills) with others in a professional and effective manner to build strong, lasting customer relationships and develop a strong team by supporting and leading group work areas.
• Ability to handle a wide variety of tasks under critical time constraints.
• Strong organizational abilities and problem-solving skills.

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, 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.

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US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:

https://www.abbvie.com/join-us/reasonable-accommodations.html