Document Control Specialist

• SUMMARY / OBJECTIVE

The Document Control Specialist is responsible for controlled documents associated with the manufacture of safe, pure, effective and quality product in accordance with company SOPs, policies and cGMPs. The Document Control specialist provides support to other departments as needed and is critical in maintaining production schedules and meeting company goals. The Document Control specialist will participate in all aspects of the Document Control Process. This includes all elements of the document lifecycle such as editing, reviewing, tracking, issuing, and filing of controlled documentation as per applicable Standard Operating Procedures.

• ESSENTIAL FUNCTIONS

To perform this position successfully, an individual must be able to perform each essential function satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

• Responsible for the revision, distribution, and maintenance of controlled documents including Standard Operating Procedures, specifications, protocols, and other miscellaneous documents.
• Responsible for maintaining controlled document library at Bright Innovation Labs Ohio Facility.

• Prepare controlled documents through the change control process including editing, proofreading, tracking, copying, distributing, scanning, and filing. Audit controlled document files and satellite files to meet audit schedule. Provide support for regulatory inspections and partner audits.
• Ensure all work is performed and documented in accordance with cGMP requirements and existing company policies and procedures. Able to perform tasks with minimal error rate.
• Perform any other tasks/duties as assigned by management.
• Promote compliance with Bocchi Laboratories policies, procedures, quality standards and current Good Manufacturing Practices (cGMP) as well as safety and environmental regulations. Participate, as required, in safety and GMP training sessions, and other company training sessions

• COMPETENCIES
  1. Working knowledge of assembly/production processes
  2. Detail-oriented
  3. Working knowledge of appropriate industry regulations
  4. Administrative skills and ability to multi-task
  5. Execution (results-oriented)
  6. Must have strong verbal and writing skills along with strong communication skills. Must be able to speak, read, and write in English.
  7. Experience using Microsoft Word, Excel, and Outlook
  8. Requires basic working knowledge for fundamental math skills
  9. Must successfully pass a background check and drug screen

• SUPERVISORY RESPONSIBILITIES
  1. This position has no supervisory responsibilities.

• CONSEQUENCES OF ERROR

1. This position audits products being (or have been) produced and has impact that can reduce the magnitude for possible quality issues through full performance in this role.

• WORK ENVIRONMENT
  1. This position functions on the production floor and therefore, will experience characteristics commonly found in a manufacturing setting. Characteristics would include (but not limited to):
     1. frequently exposed to moving mechanical parts; occasionally exposed to fumes or airborne particles. The noise level in the work environment is usually moderate.

• PHYSICAL DEMANDS
  1. The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

• POSITION TYPE/EXPECTED HOURS OF WORK
  1. This is a full-time position. The base days and hours are Monday through Friday, eight (8) hours per shift depending on shift assigned.
  2. Overtime is voluntary. However, having flexibility to working ones "fair share" of overtime as business needs may warrant also spread the overtime burden across the entire department. All overtime must be pre-approved by the supervisor or department leader.
  3. Overtime notice will be communicated as far in advance as feasible, however, based on the nature of the work overtime notice may be less than one workday at times.

• TRAVEL
  1. No travel is expected for this position.

• REQUIRED EDUCATION & EXPERIENCE

High School Diploma or GED equivalent required. Associates or bachelor's degree preferred.

• PREFERRED EDUCATION & EXPERIENCE LANGUAGE SKILLS
  1. Experience in Quality Assurance or Document Control function is preferred.
  2. Minimum 1-3 years' work experience in an FDA regulated environment is preferred.
  3. Experience in a pharmaceutical manufacturing environment is preferred
  4. Ability to read and comprehend simple instructions, short correspondence, and memos. Ability to write simple correspondence. Ability to effectively present information in one-on-one and small group situations to customers, clients, and other employees of the organization.
  5. Mathematical Skills: ability to add, subtract, multiply, and divide in all units of measure, using whole numbers common fractions, and decimals. Ability to compute rate, ratio, and percent and to draw and interpret bar graphs.

• ADDITIONAL ELIGIBILITY QUALIFICATIONS
  1. English language and knowledge of the structure and content of the English language including the meaning and spelling of words, rules of composition, and grammar.

• WORK AUTHORIZATION
  1. Must be authorized to work in the U.S. as a pre-condition of employment.

• EEO STATEMENT
  1. Bright Innovation Labs is an equal opportunity employer. Bright Innovation Labs does not discriminate on the basis of race, religion, color, sex, gender identity, sexual orientation, age, non-disqualifying physical or mental disability, national origin, veteran status or any other basis covered by appropriate law. All employment is decided on the basis of qualifications, merit, and business need.

• OTHER DUTIES
  1. Ability to apply common-sense understanding to carry out instructions furnished in written, oral or diagram form. Ability to deal with problems involving several concrete variables in standardized situations.
  2. This job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee. Other duties, responsibilities and activities may change or be assigned at any time with or without notice.

All employment offers are contingent on passing a pre-employment drug screen and background check.