What are the responsibilities and job description for the Document Control Specialist position at Acro Service Corporation?
We are seeking an Document Control Specialist to join the company, a premier supplier, in San Diego, CA US 92121 While working in this clean and climate-controlled facility you will have the opportunity to be directly involved in the evolution of the industry. Come work for a company that has been consistently recognized among the Best & Brightest Companies to Work For. Immediate interviews are available, apply today!
ONSITE POSITION - SHIFT - MON-FRI 8AM - 4:30PM - DURATION - 3 MONTHS - MAYBE TEMP TO HIRE IF SALES/VOLUME GROW.
Position Overview:
The Operations Compliance Specialist ensures patient safety, regulatory compliance, and inspection readiness by leading investigations and managing deviations and complaints with precision and accountability. This role facilitates Rapid Response Team fact-gathering, authors clear and comprehensive investigation reports, and proposes effective Corrective Action, Preventative Actions (CAPA’s) to prevent recurrence of quality events. Leveraging industry-standard Lean and Six Sigma tools, the specialist drives root cause analysis, leads cross-functional problem-solving sessions, and develops SOPs and work instructions to strengthen operational standards.
Essential Functions:
• Participate in and facilitate Rapid Response Team fact gathering
• Write Investigation reports – These written reports will clearly communicate what happened, why it happened, when it happened
• Propose CAPAs – how to prevent event from happening in the future
• Deploy industry-standard Lean and Six Sigma tools to address the root causes of non-conforming quality events
• Facilitate cross-functional problem-solving events
• Author SOPs and work instructions
• Review investigation documentation for Out Of Specifications, Out Of Trend or atypical results, as well as deviations from regulations, corporate policy or site procedures
• Manage timelines for investigations/complaints to ensure that reporting is performed on time and investigations/complaints are addressed in a timely manner
• Communicates clearly with internal and external clients, both verbal and written
• Clear understanding of related SOPs and cGMPs as necessary to accomplish daily tasks
• All other duties as assigned
Position Requirements:
Education or Experience:
• Bachelor’s degree required.
• Minimum of 5 years of relevant industry experience in a cGMP environment, or comparable pharmaceutical knowledge and experience.
• Minimum of 3 years of technical writing such as validation reports, engineering documents, controlled documents (SOPs, Batch Records, Work Instructions) in a GMP environment
Knowledge/Skills Requirements:
• Lean, Six Sigma, SPC experience (1 year preferred)
• Excellent oral and written communication skills
• Proactive problem-solving and analytical skills
• Self-motivated, disciplined, focused, work well under pressure and be able to prioritize work
• Ability to simultaneously work on several projects with the flexibility to reprioritize in a minimum amount of time
• Strong knowledge of MS Office software and query-based systems activities (e.g., Pivot Tables, VLOOKUP’s, Excel Formulas, building presentations in PowerPoint, etc.).
The Company is an Equal Opportunity Employer and is committed to creating an equitable and inclusive environment for all.
Salary : $43