NEW! Document Control Assistant, Pharma - Great Pay + BenefitsJoin Our Talent CommunityOur growth is real and we're looking for the best of the best who are committed to making a difference. We want people who are enthusiastic, rigorous, collaborative, and confident in teams. Above all, we want people who share our fundamental core values - quality, reliability, meeting customer needs, integrity, respect for each other, and collaboration.Our employees enjoy a wide array of benefits designed to provide safety and security for themselves and their families. We are proud of the benefit programs we provide, including:
- Exceptional healthcare insurance (no high deductible plan here!)
- 100% match of first 4% 401k plan and immediate vesting
- Generous time-off plan (because family is important), up to 5 weeks to start (vacay + sick + holiday)
- Many fun events throughout the year!
How this position makes a difference:This position assists in managing the data entry, filing and maintenance/storage of GMP documentation, specifically those related to the various change control processes for regulated documents and quality records to support the organization's quality systems. Assists in issuance and reconciliation of critical documentation. Assists in managing the documentation and training QMS electronic systems. Reports to the Document Control Supervisor.Your responsibilities:
- Reviews, revises, and uploads regulatory-related documents, change controls, and quality records to support the organization's documentary supportive systems
- Ensures documents and related records are compliant with approved procedures, are accurate, complete and timely.
- Ensures processes for document and change control management are conducted per approved procedures and rules.
- Performs edits and compliance checks of documents and change control records.
- Updates change control database to maintain tracking and company notifications.
- Issues original GMP documentation for filling, packaging, testing, and environmental monitoring processes and logbooks per data integrity procedures.
- Assists with inquiries and training on the use of software systems and processes associated with document and change control management.
- Creates and maintains organized files for master documents to support all documentation systems.
- Ensures timely retrieval of documents to support development, production and regulatory/customer audits.
- Performs data entry and importing of training records. Collects, and files and maintains employee acknowledgment, training, and other records that support regulatory activities.
- Maintains compliance with all company policies, quality systems, and procedures.
- Assists with special projects as required or requested.
- Promote a safe and harmonious work environment.
- Maintain compliance with SOPs, GMPs, and all company policies.
- Other duties as assigned or required.
You bring these qualities:
- An Associates or Bachelor's degree from a regionally accredited institution is preferred.
- Knowledge of good documentation practices and procedures.
- Knowledge of general computer functions such as Microsoft Office programs, spreadsheets, etc.
- Skill in handling several projects or tasks at the same time, or within a given time frame.
- Ability to recognize a safety issue or potential safety issue.
- Skill in understanding and use of quality management systems for document control.
- Skill to use time management techniques in personal daily tasks and that of others.
- Ability to apply critical thinking.
- Advanced interpersonal and communication skills.
- Ability to maintain confidentiality of all internal and external information and processes.
- Ability to follow personal hygiene standards/procedures according to SOP.
- Attention to detail and ability to ensure accurate, complete and timely documentation and records required.
- Ability to understand business rules needed for management of documents and records within a regulated environment.
- Ability to follow all appropriate SOPs and safety procedures per company guidelines.
- Ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists.
- Ability to be flexible in work hours.
- Ability to provide motivational support.
- Ability to maintain a professional, positive attitude at all times.
- Ability to trust, develop, maintain, and strengthen partnerships with others inside the organization who can provide information, assistance, and support.
- Ability to lead by example.
- Ability to communicate with coworkers, management team members, and other individuals in a courteous and professional manner.
- Ability to work in a fast-paced environment.
- Ability to pay close attention to detail and coordinate various activities simultaneously.
- Ability to complete assigned tasks.
All requirements are subject to possible modification to reasonably accommodate individuals with disabilities. The above statements are intended to describe the general nature and level of work being performed. This document in no way states or implies that these are the only duties to be performed by the employee occupying this position. Employees will be required to follow any other job-related instructions and to perform any other job-related duties requested by their supervisor. **Please note: this job posting is for the 1st Shift, Vial Pack Technician role. If you are interested in another position and/or shift, please apply to the relevant job posting. **About Us: Notice of Employee Rights, Protections, and Obligations under Labor Law Section 740: EEOC 'Know Your Rights' Poster: Employee Rights Under the Polygraph Protection Act: