Documentation Specialist

POSITION SUMMARY:

Write and execute required regulatory documentation as prescribed by the Validation Master Plan. Provide trouble-shooting and technical support to the facility in the execution of the Validation Master Plan and to support operational needs.

ESSENTIAL DUTIES AND RESPONSIBILITIES: To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skills, and/or abilities required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential function in accordance with applicable law:

¬ Manage the Document control process, unlock documents for different process owners to update documents.

¬ Issue Document control request numbers (DCR) and maintaining the log for the numbers.

¬ Send monthly remainders to process owners for documents coming up for periodic review and overdue for periodic review

¬ Issue and maintain validation protocols numbers.

¬ File production batch records and retrieval for customer complaints investigations, customer audits, recalls and internal audits.

¬ Maintain the training for the site using the corporate training system once rolled out to Morton Grove site.

¬ Ensure operating procedures and document control systems are compliant to cGMPs and federal regulations.

¬ Manage the master SOP list and update when revisions occur or SOP’s are obsoleted.

¬ Ensure operational procedures are complete for use in production and training.

¬ Identify and help eliminate non-value added processes and procedures in the operation.

REQUIRED EDUCATION/EXPERIENCE:

¬ Bachelor of Science in Technical Field such as Chemistry, Engineering, etc.

¬ Strong technical writing skills. Must have experience preparing and executing technical support documents such as but not limited to standard operating procedures [SOP], change control documentation (document, equipment, computer system), validation protocols, batch record reviews, annual drug product reviews, annual drug retain reviews, revalidation reviews (equipment and process) and critical system periodic reviews.

¬ Formal Training in Microsoft Office preferred.

¬ Four plus [4 ] years of responsibility in a quality control/quality assurance/compliance from a GMP regulated environment.

¬ Strong working knowledge of Microsoft Systems.

¬ Excellent verbal and written skills in English.

¬ Ability to interpret and document operational processes and procedures.

¬ Ability to organize documentation in a logical and concise manor.

¬ Skilled at problem solving analysis with an emphasis on details. ¬ Excellent organizational skills

¬ Communicate with other Fareva facilities and external consultants must have the ability to interact at all levels of the organization and work within a team environment.

¬ Management of documentation files and file storage

ADDITIONAL ELIGIBLITY QUALIFICATION:

¬ N/A WORK ENVIRONMENT: The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions in accordance with applicable law: The working environment includes both office and plant floor settings. Exposure to industrial noise, forklift traffic, noise, wet floors, odors, fumes, moving mechanical parts, and temperature fluctuations and extremes in operating areas of the plant. Specified PPE required in operational areas.

PHYSICAL DEMANDS: 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 in accordance with applicable law:

¬ Walking and some climbing of stairs & walkways required.

¬ Must be able to lift, bend, stoop, crouch, reach and climb.

¬ Repetitive motion of the wrists, hands, and/or fingers.

¬ Ability to lift and carry up to 30 lbs. occasionally.

¬ Sitting for extended periods of time working in front of a computer screen.

Job Type: Full-time

Pay: From $55,000.00 per year

Benefits:

• 401(k)
• 401(k) matching
• Dental insurance
• Employee assistance program
• Employee discount
• Flexible spending account
• Health insurance
• Health savings account
• Life insurance
• Paid time off
• Parental leave
• Referral program
• Vision insurance

Schedule:

• 8 hour shift
• Monday to Friday
• Morning shift

Ability to Relocate:

• Morton Grove, IL: Relocate before starting work (Required)

Work Location: In person