Careers

JOB TITLE:sr. director- quality

The Sr. Director, Quality will maintain Ash Stevens’ Quality Systems to ensure regulatory compliance in the manufacture of Active Pharmaceutical Ingredients.  The incumbent will be an integral member of the Senior Management Team.

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 safety, health and environmental procedures, policies and practices.
  • Consistent support and practice of all Ash Stevens’ mission and values.

 Key accountabilities:

  • Release or reject API: Maintaining the system to release or reject API, intermediates, starting materials, raw materials, processing aids, packaging components, and labeling; Oversee system to ensure materials are produced and tested in a manner consistent with the applicable regulatory findings; Ensure that ancillary documentation including cleaning records, environmental monitoring records, calibration records, etc. are appropriately reviewed and approved by QA; Oversee system for preparing Certificates of Analysis, Certificates of Conformance, Summaries of Test Results, BSE/TSE Certification, and Approved Labelling, as required by client; Respond to client questions and requests regarding executed batch production and testing records.
  • Inspections and Audits: Assume lead role in regulatory inspections and client audits, prepare responses to audit findings, direct implementation of corrective and preventative actions (CAPAs); lead Ash Stevens’ internal audit program, schedule audits, prepare reports, direct implementation of CAPAs; lead Ash Stevens’ external audit program, schedule audits, prepare reports, monitor contractor/supplier implementation of CAPAs; participate in implementation of quality agreements with clients, contractors, and suppliers.
  • Investigations, Corrective Action/Preventative Action: Prepare, edit, review, and/or approve deviations, out-of-specification reports, formal investigations, and non-conforming material results; prepare, edit, review, and/or approve complaint investigations; administer the Corrective Action/Preventative Action (CAPA) program for assigning, evaluating, tracking, and approving actions to ensure that commitments are satisfactorily completed on a timely basis.
  • Training: Coordinate employee training and skills assessment; conduct new employee training as required; conduct routine quality training of all employees as appropriate.
  • Records and Reports: Ensure appropriate level of quality assurance review and approval for the following protocols and associated reports: process validation, cleaning validation, analytical method validation, equipment/utilities qualification and stability; prepare reports related to equipment, processing, or testing, as requested by the client; prepare, review, and/or approve Annual Product Reviews.
  • Procedure preparation, review, and approval: Prepare, edit, review, and/or approve Standard Operation Procedures administering the Quality System; Ensure appropriate level of quality assurance review and approval for all master production procedures, specifications, and analytical test methods; ensure appropriate level of quality assurance review and approval for all procedures affecting the quality of intermediates or APIs; evaluate changes that may affect API quality and either approve or reject proposed changes (Change Control).

OTHER RESPONSIBILITIES:

  • The scope of the position dictates that support be provided to both manufacturing and development facilities in Riverview and the research facility in Detroit. The Sr. Director, Quality Assurance can anticipate that up to twenty (20) percent of their time will be in support of research activities.
  • The Sr. Director, Quality Assurance will serve as a representative of Ash Stevens, not only with clients and auditors on-site, but at off-site meetings as well. These may include meetings with clients, contractors, or suppliers, seminars, conferences, and training meetings.  The Sr. Director, Quality Assurance will be expected to represent Ash Stevens in a positive light.
  • The Sr. Director, Quality Assurance will provide technical/regulatory expertise when requested to all ASI departments and employees.
  • Participate as a speaker/committee member/panelist at outside venues including but not limited to BIO, DCAT, SOCMA, USP, ISPE.


EDUCATION/EXPERIENCE:

  • Bachelor’s degree in the physical sciences or engineering; advanced degree strongly preferred.
  • Minimum ten (10) years’ experience in the pharmaceutical industry in manufacturing operations, process development, quality assurance, and/or regulatory affairs.

 Job Competencies:

  • Extensive knowledge of GMP requirements (21CFR Part 211 and/or ICH Q7).
  • Knowledge of other industry guidance documents (such as ISPE Bulk Pharmaceutical Guide, GAMP 5).
  • Excellent organizational and planning skills.
  • Strong written, verbal, and interpersonal communication skills.
  • Have the ability to develop, perform, evaluate, and troubleshoot within a scientific discipline.
  • 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.  
 Interested candidates may send their resume to careers@ashstevens.com

 JOB TITLE: quality control DATA REVIEW Scientist

 

The Quality Control Data Review Scientist will be responsible for GMP review and comment on laboratory raw data, procedures and reports to ensure methods, protocols and other procedures were properly followed, results are analytically accurate and correct, and that all documentation meets GMP standards.

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:

  • Review IPC, raw materials, intermediates and finish products analytical data, and cleaning verification data according to cGMP and within the timeframes defined
  • Interface with their supervisor, the analytical group(s) and QA on a daily basis.
  • Review of testing data for reference standards and stability samples and validation data
  • Document review includes review of sample preparation, equipment set-up, and test results in laboratory notebooks or other appropriate test record forms, and electronic data and audit trails
  • Review of a variety of data types including HPLC, GC, KF, IR, XRPD, ICP, TGA, DSC, and wet chemistry testing
  • Review of reports for accuracy and completeness. Reports may include but not limited to: method validation reports, stability reports, etc.
  • Perform and or support lab investigations (e.g. OOS, deviations, CAPAs)
  • Assist in the preparation of new or revised documentation as required.
  • Proposes changes for continuous improvement, either in safety, GMPs, or general QC efficiency.

EDUCATION/EXPERIENCE:

  • Bachelor’s degree in Chemistry, Biochemistry or related field
  • Minimum two (2) to five (5) years of experience in using HPLC, GC, and/or related analytical techniques. QC data review experience a plus.
  • Knowledge of ECM OpenLab a plus
  • Minimum two (2) years of GMP laboratory experience

 Job Competencies:

  • Ability to monitor, coordinate and prioritize work in an effective and efficient manner.
  • Must be a self-motivated, proactive team member to manage work within quality projects and timelines.
  • Excellent organizational and planning skills.
  • Strong written, verbal, and interpersonal communication skills.
  • High attention to detail.

 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:

  • 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.

 Interested candidates may send their resume to careers@ashstevens.com


 

JOB TITLE: LABORATORY ASSISTANT

The Laboratory Assistant is responsible for cleaning the laboratories, clean rooms, and general cleaning of the facility.

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:

Maintain cleanliness of the laboratories, clean rooms, and general facility per schedule or as needed.
Maintain documentation of cleaning for labs and clean rooms per SOP or need as well at general department records.
Assist with training of new employees in department as necessary.
Ensure there is an adequate inventory of supplies in both labs and clean rooms.
Use electronic systems as needed.

 EDUCATION/EXPERIENCE:

High school diploma or equivalent.

Job Competencies:

Detail oriented, self-starter.
Ability to interact effectively within all levels of the company.
Excellent record-keeping and communication skills.

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:
  • Ash Stevens is engaged in the business of pharmaceutical research and contract pharmaceutical manufacturing. As such, all ASI staff work in or nearby either chemical/pharmaceutical research or chemical/pharmaceutical manufacturing equipment and processes.
  • 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.

 Interested candidates may send their resume to careers@ashstevens.com


 Interested candidates may send their resume to careers@ashstevens.com

Our History

Ash Stevens was founded in 1962 by Dr. Arthur Ash and Professor Calvin Stevens and is headquartered in Riverview, Michigan.

executive team

Ash Stevens is led by a highly experienced team and every client receives focused attention from experts dedicated to their project.