Documentation Associate

SUMMARY

Responsibilities include the creation of Master Packaging Records related to contract packaging.  Will handle, manage, and expedite change controls.  Will handle and manage electronic/hard copy Master Packaging Records.  Will follow up on customer inquiries as they relate to assigned documentation and compliance issues.

ESSENTIAL DUTIES AND RESPONSIBILITIES: Responsibilities performed by the Document Coordinator Level II Associate include:

• Responsible for creation of Master Packaging Record, spine/template maintenance of assigned packaging and SOP documentation related to primary, secondary, clinical, and controlled substance packaging.

• Responsible for handling, managing, and updating electronic and hard copy filing system for draft, current and obsolete SOP and Master Packaging Records/documentation.

• Responsible for revisions to MPR documentation as required to align with packaging line updates component changes and process changes.

• Responsible for directing use of MPR’s while revisions are in progress.
• Responsible for handling, managing, and updating electronic filing system for change controls.

• Responsible for issuing, executing, closing, and filing hard copy change controls.
• Responsible for issuing, tracking, and storing executed Room Cleaning, Use and Maintenance Log (RCUML) and Equipment Cleaning, Use and Maintenance Log (ECUML)

• Responsible for issuing, tracking, and storing executed Lab notebooks.
• Complete assigned CAPA duties, including execution and documentation of investigations.

• Responsible for training designated peers at management’s request.
• Responsible for providing professional and continual customer improvements with documents that support internal and external customers.

• Builds a positive team environment by supporting, mentoring, and engaging with others in a constructive manner.

• Supports and work independently as a team advisor to project management groups.
• Supports Team Lead as required.
• Supports Continuous improvement projects.

SUPERVISORY RESPONSIBILITIES:

None

QUALIFICATIONS:

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, skill, and/or ability required. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions.

EDUCATION and/or EXPERIENCE:

• Associate’s degree is required with 2 years related experience and/or minimum of (1) outside certificate of basic quality skills and practices or:

• Outside certification of basic quality skills and practices (i.e., ASQ, CQIA, CQI, CQT, etc.) is required.
• Training or a High School Degree with 2 to 4 years’ related quality experience in inspection of pharmaceutical or related industry is required.

• Knowledge of FDA regulations including cGMP’s and current industry practice is required.

• Knowledge of the current pharmaceutical industry or Sharp packaging practices is desired.

• Good written and oral communication skills required.
• Good organizational skills, an eye to detail and time management skills are required.

MATHEMATICAL SKILLS:

Ability to apply mathematical operations to such tasks as they apply to the pharmaceutical industry.  This includes an evaluation of statistical sampling plans.

LANGUAGE SKILLS:

• Ability to read and interpret common scientific data. Ability to respond to common inquiries or complaints from customers. Ability to effectively present information to the following groups:

• Internal: Frequent contact with Quality Department and Operations Department employees for information on quality documentation issues and cGMP issues.
• External: Occasional contact with customer representatives related to documentation.

REASONING ABILITY:

• Ongoing contact with internal Operations and Quality Department employees. Occasional contact with customer representatives concerning compliance with specifications, as well as cGMP’s.

• Customer agreements and regulatory guidelines are available to assist, however frequent review and reasonable interpretation are necessary to keep current.  A thorough internal audit and follow-up program is necessary to prepare for customer audits and regulatory inspections. 

• Good organizational skills are necessary. Good mental skills for analysis and problem solving are needed.

COMPUTER SKILLS:

• Strong familiarity with MS Office applications such as Excel, PowerPoint, MS Word, Visio, etc. is required.
• Veeva and SharePoint

CERTIFICATES, LICENSES, REGISTRATIONS:

Must have a valid driver’s license.

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 accommodation may be made to enable individuals with disabilities to perform the essential functions.

While performing the duties of the job, the employee is regularly required to sit, stand, walk, and pay attention to detail.  The employee must occasionally lift and/or move up to 10 pounds. 

WORK ENVIRONMENT:

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions.