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Document Control Technician I
Waunakee, WI
Job Description
Scientific Protein Laboratories (SPL) is a biopharmaceutical leader in the development and manufacturing of heparin, pancreatin, heparin derivatives, naturally derived pharmaceuticals, and recombinant proteins from microbial fermentation. We have an immediate opening in Waunakee, WI (Madison area) for a Document Control Technician I.
The Document Control Technician I generates, reviews, revises, and issues current and new controlled documents under general supervision. They assist in current operations in the document department. The Document Control Technician provides traceability and accountability through control and release of documents as required by corporate and current Good Manufacturing Practices (cGMP).
DUTIES AND RESPONSIBILITIES
JOB STANDARDS:
Education:
The Document Control Technician I generates, reviews, revises, and issues current and new controlled documents under general supervision. They assist in current operations in the document department. The Document Control Technician provides traceability and accountability through control and release of documents as required by corporate and current Good Manufacturing Practices (cGMP).
DUTIES AND RESPONSIBILITIES
- Assure appropriate issuance and retrieval of controlled documents. Assure return or retrieve outdated or obsolete documents; assure all previously issued copies are accounted for and destroyed. Maintain relevant databases.
- Issue product batch/packaging records and properly assign lot numbers based on established procedures and production schedules
- Assist in editing controlled documents for proper format and content per existing Standard Operating Procedures and cGMP guidelines
- Assign and route controlled documents in accordance with document control SOPs. Assign “effective dates” and copies and places new or revised SOPs in proper locations throughout the facility.
- Maintain files on all controlled documentation. Files, scans and archives controlled documents
JOB STANDARDS:
Education:
- Minimum of a high school diploma or G.E.D.
- Less than 6 months relevant experience
- Experience in a research setting is highly desirable.
- The candidate must be accountable, bringing analytical skills and attention to detail.
- Experience in decision-making is desirable, with good interpersonal and communication skills.
Job Summary
Company
Start Date
2/7/17
Employment Term and Type
Regular, Full Time
Required Education
High School or Equivalent
Required Experience
0 to 1 year
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