Document Control Specialist

Summary:Our client is seeking to hire a Quality Assurance/Document Control Specialist. The right person will maintain overall document control structure within the Company document management system. Responsible for the implementation, management, and maintenance of the document management system in accordance with the Quality System and relevant regulatory requirements. Perform quality assurance duties under limited supervision. Works in accordance with Company Standard Operation Procedures (SOP).Principal Tasks & Responsibilities:1. Manage both paper and electronic records to ensure that controlled records are created, circulated, reviewed, issued, retained, stored and maintained in a manner that meets requirements2. Responsible for Document Control Orders (DCO) completeness, accuracy, and implementation3. Maintain DCO log and Controlled Document Master list database4. Administer training documentation for regulatory purposes and manage training database5. Assist in the revision of SOP for quality assurance activities6. Release finished goods and maintain Device History Records as required7. Review inspections records and lot history records according to defined criteria and specifications8. Manage incoming inspection and Returned Good inventory log. Maintain and assist in administrating all QMS requirements. For example, CAPA, NCMR, etc.9. Maintain equipment flies, equipment list and schedule required equipment calibrations10. Maintain supplier files and key supplier list11. Assist with other administrative duties as assigned/requiredQualifications:Education: High school diploma or GED required. AA degree preferred.Experience: 3 years of QA-Doc Control experience, preferably from medical device industrySkills:• Well organized and accurate in work deliverables• Attention to details: able to identify inconsistences and stay focused with repetitive tasks• Ability to work independently: able to self-regulate work pace and meet deadlines• Strong written and verbal communication skills• Computer proficient in MS Word and Excel• Knowledge of ISO Quality Standards (ISO 9000 or ISO 13485) and QSR, and GMP requirements About Advantage Resourcing Advantage Resourcing is committed to providing equal employment opportunity for all persons regardless of race, color, religion (including religious dress and grooming practices), sex, sexual orientation, gender, gender identity, gender expression, age, marital status, national origin, ancestry, citizenship status, pregnancy, medical condition, genetic information, mental and physical disability, political affiliation, union membership, status as a parent, military or veteran status or other non-merit based factors. We will provide reasonable accommodations throughout the application, interviewing and employment process. If you require a reasonable accommodation, contact us. Advantage Resourcing is an E-Verify employer. This policy is applicable to all phases of the employment relationship, including hiring, transfers, promotions, training, terminations, working conditions, compensation, benefits, and other terms and conditions of employment. All employees are directed to familiarize themselves with this policy and to act in accordance with it. All decisions with respect to employment matters and other phases of employer-temporary employee relationships will be in keeping with this policy and in accordance with all applicable laws and regulations.