Doc Control Specialist/Analyst in Cary, IL at Stryker Corporation

Date Posted: 8/9/2019

Job Snapshot

Job Description

Essential Duties & Responsibilities

  • Conduct cGMP and QS documentation control functions (paper and electronic).
  • Administer Product Data Management (PDM) system housing QMS documentation and change control records.
  • Perform assessment(s) of documentation control system(s), propose improvement to current document control policies and practices and implement as directed.
  • Maintain a scheduled review of documents (e.g. SOP’s, QTP, etc.) by process owners.
  • Maintain document library, filing of documents, maintaining master copies and various other databases for documents not residing in the PDM system.
  • Update Manufacturing Execution System (MES) for approved revisions.
  • Control CGMP documents.
  • Respond to Doc. Center inquiries and requests.
  • Training for employees at all levels in basic use of the PDM system and other related cGMP and QS training, as assigned.
  • Participate in Doc Center improvement initiatives as assigned.
  • Serve as primary backup for records/retains and stability pulls.

Education & Special Trainings

  • Associates degree required; Bachelors preferred
  • Experience working in an FDA regulated industry preferred
  • Good communication and organizational skills
  • Detailed oriented
  • Dependable and willing to learn
  • Ability to take direction and work independently, as needed
  • Ability to function in and around Microsoft Office (e.g. Word, Excel, PowerPoint, Access)
  • Experience writing and or creating SOP’s, forms (checklists), diagrams, spreadsheets preferred

Qualifications & Experience

Work experience in an FDA regulated environment (cGMP, cGDP and 21 CFR part 11 regulations) preferred

Reports to

              Associate Supervisor, Document Control

Job Location

              Cary, IL

Percent of Travel

              5%

Physical Requirements

  • Standing, walking, sitting, hearing, fingering, grasping
  • Minimal physical activity
  • Must be able to read and review quality control procedures.
  • As a rule, the Doc Control Specialist/Analyst is subject to controlled indoor conditions with some temperature change from occasional tasks outdoors or in the warehouse
  • When backing up stability pulls - Inside and outside conditions, excursions up to 40C / 75% relative humidity, wet, noise, hazards, odors, dust, usual office environmental condition.

Mental Requirements:

  • Reading comprehension
  • Organization
  • Data interpretation

Work From Home: No

Travel Percentage: Up to 25%

Stryker Corporation is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, or protected veteran status. Stryker is an EO employer – M/F/Veteran/Disability.

Stryker Corporation will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor’s legal duty to furnish information.

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