Operations Support Specialist – Document Control Kelly Science and Clinical is currently recruiting for qualified, full-time, contract to potential permanent Operations Support Specialist – Document Control in Rochester, Michigan area for one of our clients in the pharmaceutical space. The need to fill this position is immediate.
Summary: This person will support deviation and investigation work, driving to the root cause and supporting CAPAs. This person will also need to understand the process quickly and understand improvements needed to be made.
Qualifications/Education/Skills: Bachelor s Degree in a relevant field such as Business Administration, Technical Writing, Engineering, or a field related to the industry required– 5+ years of experience within a pharmaceutical industry may be considered in lieu of BS degree. 3-5+ years ideally within a pharma industry desirable plus degree; open to experience within other industries within a regulated environment
CAPA and technical writing experience a plus. Experience with any combination of the following would be preferred for a candidate that could support CAPA initiative:
Process Understanding : A deep comprehension of the processes, workflows, and tasks within the organization is essential. This includes understanding the intricacies, dependencies, and critical steps involved.
Clear Communication Skills : SOPs are all about clarity. The ability to articulate complex procedures in a concise, straightforward manner is crucial. Writers should be adept at breaking down processes into step-by-step instructions.
Attention to Detail : SOPs must be accurate and precise. Writers need to pay attention to every detail, ensuring consistency and correctness.
Regulatory Knowledge : Depending on the industry, SOPs may need to adhere to specific regulations or standards. Familiarity with regulatory bodies (such as OSHA, EPA, DOT, FDA) and their requirements is valuable.
Industry-Specific Expertise : Understanding the nuances of the industry or field where the SOPs will be applied is advantageous. Different sectors (e.g., manufacturing, healthcare, finance) have unique processes.
Quality Management : Knowledge of quality management principles (e.g., Six Sigma, ISO 9001) helps maintain high standards in SOPs.
Collaboration Skills : SOPs often involve input from various stakeholders. Writers should collaborate with subject matter experts, managers, and team members to gather information and validate procedures.
Document Formatting : Proficiency in using tools like Microsoft Word or PowerPoint to create well-structured SOPs is essential. Templates and consistent formatting enhance readability.
Risk Assessment : Identifying potential risks and incorporating preventive measures into SOPs ensures safety and compliance.
Version Control : Understanding version control practices helps manage updates and revisions to SOPs effectively.
Pay : $72-80K/yr and based on experience
Hours: M-F, 8AM – 5PMEST; a hybrid work schedule is an option, with 1-2 days offsite and 3-4 days onsite
For immediate consideration or more information, please contact me directly at or at .
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