Document processor serp_jobs.h1.location_city

Document Control Position

This Document Control position is concerned with the generation and maintenance of Document Control records and departmental SOPs and batch records. The incumbent will be responsible for the day to day tasks in this key quality system through adherence to company and departmental procedures.

Major Position Activities & Responsibilities :

• System Administrator of the electronic documentation system : supporting users by answering questions, one-on-one training, trouble shooting, working with IT on specific cases, and providing support for any changes made to the system via Modification Change.
• Controls Administrator for Training System : updating / creating training materials (JQRs and TACs), creating curriculums / training for procedures / updates / processes, and assigning training to the required individuals.
• Technical judgment in decision making and technical training of departmental peers Initiating / owning / investigating exceptions and issues related to Document Control in the Quality Tracking System.
• Processing change orders, drafting documents, editing and processing of documents in the electronic document system.
• Answering questions, customer assistance with drafting / requests from individual users Issuance and logging of batch records, check sheets and associated forms.
• Maintaining electronic document repositories and document share file directories Logging in / auditing / searching / filing of documents Issuance, tracking and archiving of all LUMAC, QC Data, and other GMP logbooks Preparation of departmental metrics.
• Document Control representative on interdepartmental teams and projects
• Expediting requests to the Doc Center Updating / creating Document Control SOP Processing / expediting document requests from Regulatory, and placing them into the designated site for each submission
• Performs special projects and other duties as assigned.
• Providing documentation support during regulatory inspections / external audits of the facility.
• Serves as a delegate for Manager, Training and Document Control when needed.
• This position is non-supervisory, and performance is tracked through various departmental and company metrics. The incumbent is expected to trouble shoot Doc Center problems.

Minimum Qualifications :

Preferred Qualifications :

Pay Range for this position : $95,100-$142,700

The offer range represents the anticipated low and high end of the base pay compensation for this position. The actual compensation offered will be determined by factors such as location, level of experience, education, skills, and other job-related factors. Position may be eligible for sales or performance-based bonuses. Benefits offered by the Company include health insurance, paid time off (PTO), retirement contributions, and other perquisites.

The Company is an Equal Employment Opportunity employer. No employee or applicant for employment will be discriminated against on the basis of race, color, religion, age, sex, sexual orientation, national origin, ancestry, disability, military or veteran status, genetic information, gender identity, transgender status, marital status, or any other classification protected by applicable federal, state, or local law. This policy of Equal Employment Opportunity applies to all policies and programs relating to recruitment and hiring, promotion, compensation, benefits, discipline, termination, and all other terms and conditions of employment. Any applicant or employee who believes they have been discriminated against by the Company or anyone acting on behalf of the Company must report any concerns to their Human Resources Business Partner, Legal, or Compliance immediately. The Company will not retaliate against any individual because they made a good faith report of discrimination.