Document Control Supervisor

Description

Agility, Impact, Methodology. Do you exhibit these values and wish to be around others that do too? Do you thrive in fast-paced environments where agility, adaptability, and high standards go hand in hand? Are you driven to make a meaningful impact, whether through your work, your support of others, or your commitment to your community? Are you motivated by a disciplined, science-based approach that ensures consistent excellence, safety, and integrity in everything you do? If these statements resonate with you, Grand River Aseptic Manufacturing (GRAM) welcomes you to apply to join our community of dedicated individuals improving lives every day!

Overview of this Position:

The Document Control Supervisor is responsible for leading the GRAM Document Control Technicians in support of cGMP operations, which includes managing and executing the processes associated with the issuance, reconciliation and archival of controlled documents. This position manages, coordinates, and maintains quality and process documentation, procedures, and records to ensure controlled documents are issued, distributed, reconciled, and archived in support of a quality manufacturing operation. This is an on-site position working 1st shift, but must maintain a level of flexibility to support 24/7 operations.

Non-Negotiable Requirements:

• Bachelor's Degree in Life Sciences and 2 years relevant experience working in the Biotechnology, Pharmaceutical, or relevant comparable industry. Equivalent work experience will be considered.
• Must have proficient computer skills in Microsoft Word, Excel, and Outlook.
• Exhibits a good understanding of general quality assurance concepts and practices.
• Successful history of solving problems of moderate complexity.
• Possess strong computer and Internet skills, including online document management software.

Preferred Requirements:

• Familiar with project management methodology and process.
• Prior leadership experience.

Responsibilities Include (but are not limited to):

• Facilitate the life cycle of master documents (including but not limited to SOPs, Batch Records, Test Methods, Protocols, Reports, Specifications, etc.) by functioning as a document workflow coordinator.
• Supervise the on-site documentation process to ensure proper and continuous document control support.
• Supervise the work of Document Control Technicians assisting in the QA/QC Document Control process.
• Provide hands-on leadership, coaching, and coordination of needed actions with a focus on achieving departmental and organizational goals.
• Write and revise Document Control Standard Operating Procedures (SOP).
• Write, review, and participate in investigations related to Document Control activities.
• Create and oversee the proper and timely issuance, implementation, maintenance, and archival of controlled documentation.
• Ensure controlled document issuance, reconciliation, and archival occurs according to SOPs.
• Support offsite storage activities including sending and retrieving boxes from storage. Manage storage database run reports for retention and metrics.
• Assist in internal and external audit preparation and reconciliation.
• Facilitate the document retention process, managing destruction schedules, and coordinating with offsite records vendor and client.
• Support internal, client, and external regulatory inspections by providing documents from the MasterControl DMS, including offsite searching, electronic and physical retrieval from vendor.

Full job description available during formal interview process.

What Sets GRAM Apart from Other Employers:

MEDICAL BENEFITS starting day 1: Medical, prescription, dental, vision, life insurance, and disability benefits are available to you and your family on your first day of work, with the company paying a portion of the cost! Once eligible for the 401(k) program, all your contributions are immediately 100% vested, and you are immediately vested in GRAM contributions as well. We also offer generous off-shift premiums!

Paid VOLUNTEERISM starting day 1: GRAM encourages giving back to our community by offering 16 hours of paid volunteer time per calendar year!

PTO: Full-time employees accrue up to 13 days of time off per calendar year. You choose how to use this time for your vacation, sick, or mental health needs!

WELLNESS TIME OFF: Employees earn 1 hour of time off for every 30 hours worked to use how you choose.

PAID HOLIDAYS: We offer 10 paid holidays per calendar year with immediate eligibility!

PAY: Depends on Experience and is discussed during the interview process.