SMC Ltd. was developed around a commitment to its people and customers. This continued as a global leader in contract manufacturing for medical device, diagnostics and drug delivery companies.
Located in beautiful Santa Rosa, CA, SMC, Ltd. is a globally recognized premium supplier to the medical market with locations throughout the world. People committed to speed, technology, and exceptional performance are the cornerstone of our organization. Comprised of dedicated people and decades of manufacturing experience, we have continued to experience strong growth and currently have outstanding career opportunities for equally dedicated people.
In the role of a Document Control Administrator, you will.be responsible for developing, implementing, administering, and improving document/record control processes in accordance with policies, procedures, and customer requirements. Manage the release of production documentation and oversee the control of GMP documents including the storage and retrieval of batch records, SOPs, and protocols.
Essential Job Duties and Responsibilities: - Primary administer for the Document Control System.
- Creates, prepares, issues, maintains, and revises all binders.
- Prepares all customer required certifications.
- Prepares labels required for the scheduled work orders.
- Manages, releases and retrievals of production binder's dependent upon production schedule sequence and readiness.
- Administers the Engineering Change Process for New Revisions (under engineering supervision).
- Reviews Work Order Sheets on daily basis.
- Files and stores electronic/hardcopy quality records.
- Coordinates Mold Release Agreement Initiation and ECO / Inactive Molds.
- Reviews all documentation of existing binders to ensure all is current prior to issuing to the floor. Maintains and controls all binders in order to know their location at all times.
- Prepares, files and secures C of C's, C of M's, ROHS, MSDS', REACH documentation and other requirement certifications.
- Troubleshoots material and product traceability issues as appropriate.
- Reviews Contracts Reviews Packets by ensuring that the print revision level matches the P.O.'s and that the material is correct per print. Confirm the inspection instructions are correct per P.O.
- Reviews customer supplied prints to ensure that New Revision ECO's are correct and routed to the appropriate personnel be it material, process, or document change. Subsequent release of all documents in IQ libraries.
- Reviews binders to ensure the information is correct and current.
- Receives or creates, scans, files, stores and secures quality records for the duration as required by the customer, internal or regulatory standards or specifications.
- Creates, writes, and revises documents such as procedures, work instructions, forms, II's, protocols, or guidelines for Document Control and all other departments within SMC.
- Initiates trend analysis for departmental review ie. ECO's, C of C;s, binders, etc.
- Preform other duties as assigned.
Essential Qualifications: - High school diploma or equivalent required.
- Strong interpersonal and communication skills.
- Ability to work well in a team environment.
- Must be a self-starter, able to work with minimum supervision.
- Must be proficient in counting and math.
Desirable Qualifications: - Experience within the medical device industry.
- Previous experience with lean manufacturing concepts.
ADA Requirements: - Typically sits, grasps items and performs keyboarding for frequent operation of a computer
- Stand, walk, bend, reach or otherwise move about regularly
- Lift, move, or otherwise transfer items up to 40 lbs. occasionally, >20 lbs. frequently
- Occasional exposure to typical machine shop physical hazards
We are committed to fair and equitable hiring with salaries based on relevant factors, such as work experience, education, and certifications. Toward the principle of equal pay for equal work, we post and hire within defined salary ranges. We ask all applicants to review salary ranges for each posted job opportunity, as we will not hire outside the predetermined range.
Hourly Range $25.00 - $30.00 / hour