Partner Therapeutics (PTx) is a commercial biopharmaceutical company committed to improving the lives of patients with cancer and other serious diseases. Our dedicated team brings a rigorous approach to science, establishes deep partnerships with medical and scientific communities, and works tirelessly to expand potential treatment options and address unmet medical needs.

Position Description

The Quality Systems Specialist is responsible for supporting records and document management activities for our Quality function. This position reports to the Supervisor of Quality Systems at the Lynnwood, WA manufacturing facility and is responsible for these and other activities supporting cGMP operations.

KEY RESPONSIBILITIES

• Receives, indexes, and files Quality, Manufacturing, and other Scientific records submitted for archival
• Maintains records management database(s) 
• Follows standard operation procedures (SOPs) governing their activities and maintains compliance requirements at all times
• Supports inspections conducted by internal auditors and external agencies
• Supports Quality Systems projects for system implementation and continuous improvement
• Supports administration of the electronic quality management system (MasterControl) including but not limited to user account management, workflow management, and library updates
• Provides instruction and technical support in the use of electronic quality management system software and processes
• Performs review, formatting, and routing of documents using electronic document management system
• Verifies scanned records against physical originals
• Verifies completeness of scanned records for archived materials
• Packs and indexes boxes for offsite storage
• Other responsibilities may be assigned during the course of the year.

Requirements

• High school diploma or GED required. BA, BS or equivalent preferred.
• 3 plus years of experience in records management in a highly regulated environment or medical setting required
• Proficiency with MS Office, with particular emphasis in use of Word, Excel, and SharePoint required. Advanced skills in Microsoft Word and Excel strongly preferred.
• Familiarity with electronic records management, document management, or quality management software (EDMS/QMS/RIMS) required.
• Proven ability to solve complex problems with high attention to detail and ability to find errors or inconsistencies
• Solid English language skills, both oral and written, required: Writes clear and concise procedures using company templates; Can clearly expresses ideas, opinions, and questions, and can give effective internal presentations, with coaching, including training to Team members and within departmental subgroup.
• Proven ability to work collaboratively across multiple functions and with team members having varying degrees of expertise and technical skills required
• Prolonged sitting and/or standing required
• Extensive work in front of video monitors
• Ability to lift up to 25 pounds – Job involves shelving file folders and binders requiring the individual to raise arms above head intermittently
• Intermittent use of stepladder

PREFERRED REQUIREMENTS

• Experience using databases preferred.
• Experience in healthcare, pharmaceutical, medical device, biotech, food manufacturing, environmental laboratory, or other regulated environment preferred.
• Knowledge of GxP regulations and guidance documents pertaining to Documents, Training, and/or Records Management preferred.

To ensure we are able to consistently provide Leukine to patients around the world and in support of our friends, families, and neighbors, Partner Therapeutics requires all current and future employees to be fully vaccinated against COVID-19. We require evidence of COVID-19 vaccination prior to hire, subject to reasonable accommodation and other requirements of applicable federal, state, and local law.

In addition to medical, dental, vision, FSA/DCA, HRA, disability, and life insurance coverage, all full-time, regular Partners enjoy a casual, and Hybrid or Remote workplace program for many roles. We offer a terrific compensation/benefits/perks package which includes pre-IPO options, annual cash bonuses, 401k matching, free parking or Seattle-area ORCA pass, tuition assistance, plus rewards for achievement and contribution. To support a healthy work-life balance we also provide a gym subsidy, wellness participation programs, and a generous vacation, sick, and holiday paid time off program in addition to a paid shutdown between the Christmas and New Year’s holidays.

Partner Therapeutics is an Equal Opportunity Employer and does not discriminate on the basis of race, color, religion, sex, age, national origin, veteran status, marital status, sexual orientation, gender identity, disability or any other category prohibited by local, state or federal law. This policy applies to all aspects of employment, including recruitment, placement, promotion, transfer, demotion, compensation, benefits, social and recreational activities, and termination.