POSITION SUMMARY: The Quality Document Control Specialist is responsible for managing and overseeing document change requests through MasterControl, supporting both commercial manufacturing and process development at our Riverview, Michigan site. This position is also responsible for:

• Managing associated document training courses and job code assignment, and 
• Training for the Document Management Workflow Process. 
• Providing administrative support to the Quality Assurance and Regulatory Affairs team. 
• Principal assignments related to compliance may include document management and training administration in MasterControl to ensure implementation of new and revised documentation to support ASI Quality Systems. 

To perform this position successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill and/or ability required.

• Shall adhere to all regulatory requirements, including FDA, EPA, OSHA, and related safety, health and environmental procedures, policies and practices.
• Consistent support and practice of all Ash Stevens’ mission and values.
• Identify and protect the original technical information as part of the company property.

Key accountabilities: 

• Provide administrative support such as:
  • Computer data entry.
  • Copying and/or filing of documents; maintain QA file room and archive/offsite storage.
  • Maintain employee training files.
  • Report preparation.
• Administration of MasterControl for all regulated documents.
• Identify training needs and organize training interventions to meet quality standards
• Issuance of regulated documents to end users for use in manufacturing and testing.
• With direction from other departments, make edits to existing procedures or create new procedures as appropriate. After review and approval, issue new or revised procedure to applicable employees.
• Maintain master index, including date of last review. In addition, prepare quarterly periodic record review document list for management review.

EDUCATION/EXPERIENCE: 

• High School diploma/GED required; Associate’s degree in a science field preferred.
• Two (2) to four (4) years’ administrative experience; scientific or engineering environment a plus.

job competencies: 

• Excellent organizational and planning skills.
• Strong written, verbal, and interpersonal communication skills.
• Demonstrated strong analytical skills, and the ability to work independently against multiple deadlines.

Physical demands and work environment:

The physical demands and work environment described here are representative of those that must be met by a team member to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

• Physical Demands:
  • Frequent lifting, bending, stooping, squatting, pushing and pulling can be expected.
  • Long periods of sitting and walking may also be expected in this position. 
  • This position may require long periods of sitting, typing, computer entry or looking at a computer.
• Work Environment:
  • Potential limited exposure to hazardous chemicals.
  • Personal protective equipment including safety glasses, lab coats, gloves, specialized clothing including laboratory uniform and appropriate shoes may be required in areas associated with this position.

 ABOUT US: 

Ash Stevens is a full-service pharmaceutical contract manufacturer (CMO) offering comprehensive small-molecule drug substance development and cGMP manufacturing services of active pharmaceutical ingredients (APIs). With over five decades of experience, Ash Stevens is committed to providing the highest quality of service and delivering on time, and on budget. 

In August 2016, Ash Stevens was acquired by Piramal Pharma Solutions (PPS), a world leader in pharmaceutical manufacturing. In partnering with Piramal Pharma Solutions, Ash Stevens rounds out an on-going effort to offer strategic partnerships and a total solutions approach to our customers. PPS has three North American locations – a sterile injectable facility in Lexington, Kentucky; a complex, high value API facility in Toronto, Canada, and Ash Stevens, a high-potency API facility, located in Riverview, Michigan.

Ash Stevens has extensive experience developing and manufacturing APIs for Life Science companies developing innovator small-molecule therapeutics. Ash Stevens is a long-time provider of contract research services to the National Institutes of Health and the National Cancer Institute, and has participated in the development of many important drugs through these government agencies. To date, Ash Stevens has received fourteen FDA manufacturing approvals for innovator APIs, including a number of fast-track manufacturing approvals for the active ingredients for the oncology drugs Velcade®, Vidaza®, Clolar® and Iclusig®. 

Services offered by Ash Stevens include process development and scale-up; cGMP manufacturing; development and cGMP manufacture of highly potent APIs using barrier-isolation technology; comprehensive analytical capabilities (including method development, stability studies and qualification of reference standards); and regulatory support for all phases of drug development and manufacturing.