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, V