Documentation Associate

Sharp Packaging Services • Allentown, PA

19h

About The Position

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.

Requirements

• 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.
• Good written and oral communication skills required.
• Good organizational skills, an eye to detail and time management skills are required.
• Ability to apply mathematical operations to such tasks as they apply to the pharmaceutical industry. This includes an evaluation of statistical sampling plans.
• 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.
• 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.
• Strong familiarity with MS Office applications such as Excel, PowerPoint, MS Word, Visio, etc. is required.
• Must have a valid driver’s license.

Nice To Haves

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

Responsibilities

• creation of Master Packaging Records related to contract packaging
• handle, manage, and expedite change controls
• handle and manage electronic/hard copy Master Packaging Records
• follow up on customer inquiries as they relate to assigned documentation and compliance issues
• creation of Master Packaging Record, spine/template maintenance of assigned packaging and SOP documentation related to primary, secondary, clinical, and controlled substance packaging
• handling, managing, and updating electronic and hard copy filing system for draft, current and obsolete SOP and Master Packaging Records/documentation
• revisions to MPR documentation as required to align with packaging line updates component changes and process changes
• directing use of MPR’s while revisions are in progress
• handling, managing, and updating electronic filing system for change controls
• issuing, executing, closing, and filing hard copy change controls
• issuing, tracking, and storing executed Room Cleaning, Use and Maintenance Log (RCUML) and Equipment Cleaning, Use and Maintenance Log (ECUML)
• issuing, tracking, and storing executed Lab notebooks
• Complete assigned CAPA duties, including execution and documentation of investigations
• training designated peers at management’s request
• 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

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Education Level: Associate degree