Document Control Supervisor 

We are currently seeking a qualified individual for the position of Document Control Supervisor. This position is responsible for the Document Control system and function of the company. Responsibilities include assuring organization, controlling, tracking and maintaining of documents, master SOP’s, forms, Protocols, Final Reports, customer supplier surveys, and customer files in electronic and hard copy format. 

The ideal candidate must have proven organizational skills, intermediate skill level on MS Office suite, ability to multi-task in a fast paced environment and experience in an FDA regulated environment working with International Standards and Regulations.  

Requirements: 

• Minimum five years experience in a Document Control position, preferably in a medical device environment, complying with FDA, GMP, ISO, and other regulatory and legal requirements.
• Four years post-secondary degree in a related field desired.
• Excellent interpersonal communication skills, written and verbal skills.
• Ability to work well with individuals from diverse functional areas across internal and external organizations.
• Ability to deliver and ensure accuracy in all documentation areas.
• Ability to read and proof read documents for correct grammar and spelling.

Biotest Laboratories, Inc. is an equal opportunity employer.  

Please e-mail resume and salary requirements to hr@biotestlabs.com or fax to 763-785-9054.

Document Control Coordinator 

We are currently seeking a qualified individual for the position of Document Control Coordinator. This position supports the Document Control function of the company and is responsible for organizing, controlling, tracking and maintaining documents, master SOP’s, Forms, Protocols, Final Reports, customer supplier surveys, and customer files in electronic and hard copy format.
 
 Requirements: 

• Minimum two years experience in a Document Control position, preferably in a medical device environment, complying with FDA, GMP, ISO, and other regulatory and legal requirements.
• Two years post-secondary degree in a related field desired.

• Ability to deliver and ensure accuracy in all documentation areas.
• Ability to read and proof read documents for correct grammar and spelling.
• Intermediate skill level on MS Office suite.
• Excellent interpersonal communication skills, written and verbal skills.
• Ability to work closely with team members and interface effectively with all departments.

Biotest Laboratories, Inc. is an equal opportunity employer.  

Please e-mail resume and salary requirements to hr@biotestlabs.com or fax to 763-785-9054.

Manufacturing Analysis and Development

Biotest Laboratories, Inc., located in a northern Minneapolis suburb, is a dynamic contract support organization for medical device companies.  We offer a full spectrum of outsource services that include Laboratory Testing, Manufacturing/Packaging, Production Testing/Inspection, Validation, Steam Sterilization, Cleanroom/Cleanbench Certification, Consulting and Training to serve the expanding needs of the medical device manufacturing community.   

We are experiencing growth and are currently seeking a qualified individual for the position of Manufacturing Analysis and Development . This is a support position to the Manufacturing Dept. which includes coordination of development of manufacturing department processes, systems and procedures. 

Responsibilities include development and review of existing and new standard operating procedures, evaluation of manufacturing process challenges and preparation of proposals for resolution. Additional responsibilities include the documentation and review of product specifications and support of development of in-process testing and/or inspections creation and update of process flow mapping of existing production lines.  

Requirements: 

• Four years experience in medical device, pharmaceutical, food or other manufacturing positions, complying with GMP, FDA and other requirements.

• Three years experience writing procedures relevant to medical device or pharmaceutical manufacturing processes.

• Proven ability to interface with internal and external individuals regarding factors relevant to manufacture of medical devices or pharmaceutical products.

• Ability to work well with employees within the manufacturing area, as well as, with all functional areas of the company.

• Willing to work on variable schedule as unexpected events occur.

• Ability to work with computers, Microsoft Office applications, Excel, and other related software.

• Ability to organize and communicate complex information.

This is a full time position. Salary is commensurate with experience. Biotest Laboratories, Inc. offers an excellent benefits package that includes health, dental life and disability insurances, 401(k) plan, paid sick leave and vacation.  

Biotest Laboratories, Inc. is an equal opportunity employer.  

Please e-mail resume and salary requirements to hr@biotestlabs.com

or fax to 763-785-9054.