Biopharma Quality Assurance Supervisor/Associate

Recruiter
Colorado State University
Location
Fort Collins, Colorado, United States
Posted
11 Feb 2018
End of advertisement period
11 Mar 2018
Ref
53832
Contract Type
Permanent
Hours
Full Time

Description of Work Unit

BioMARC is a contract manufacturing organization (CMO) of FDA regulated products. It was created to fill an industry need for higher containment biologic manufacturing. BioMARC is a nonprofit CMO owned and operated by CSU,and was created to translate and produce biopharmaceutical products for non-clinical, clinical, and commercial use under Biosafety level 2, 3 and Select Agent biosecurity conditions. In addition to manufacturing and testing services, BioMARC offers product and process development services, which includes the creation of development programs focused on implementing cGMP regulations and scalability issues.

This open application pool is a continuous, year-long advertisement for those candidates interested in applying to the Supervisor/Associates pool. Open positions may not be available at the specific time of your submission; however, once a position becomes available, candidates in the pool will be screened.

Position Summary

Under the direction of senior Quality Assurance (QA) staff members, QA Associates are responsible for basic QA activities to support the ongoing quality system and cGMP campaign activities. Must be able to review and audit documentation for compliance to good documentation practices and to the technical requirements of directive documents (SOPs, protocols, directive documents, etc.). The QA Associates review testing, quality control, development study and other reports/data-forms for accuracy, completeness and compliance to requirements to ensure that QA standards and regulatory requirements are met. Assist the organization with change control procedures and events. Reviews QA standards, studies existing policies and procedures, and interacts with personnel and clients to evaluate effectiveness of QA program and assists in writing QA policies and procedures. Participates in internal and external audits and assists departments with the coordination of audit information, and recommends appropriate improvement/mitigation. Assists with the monitoring of incidents and CAPAs; supports the mitigation, closure and archiving plans for incidents/CAPAs as well as all other documentation of the organization. Keeps the Director informed of the status of the quality system and unusual occurrences. QA Associates should strive toward a growing knowledge of commonly-used QA concepts, practices, and procedures within cGMP field and is responsible for improving one’s knowledge base of current QA regulations and for informing the Director of any new and/or revised regulations. Relies on instructions and pre-established guidelines to perform the functions of the job, but also have the ability to think critically and work independently; must have above average communication skills (writing and speaking) and be responsible for supporting a healthy working environment between other departments where QA is concerned. May oversee personnel engaged in QA support activities. Perform other assigned duties as necessary.

Required Job Qualifications

Research Associate I:

  • 0-3 years of professional experience
  • Bachelor’s degree

Research Associate II:

  • +3 years of professional experience
  • Bachelor’s degree
    or
  • Master’s degree

Research Associate III:

  • +5 years professional experience
  • Bachelor’s degree
    or
  • +2 years professional experience
  • Master’s degree
    or
  • PhD in the sciences

Preferred Job Qualifications

  • Experience in a contract manufacturing organization
  • Experience in a quality system in support of biopharma activities
  • Experience in a regulated environment.

Diversity Statement

Reflecting departmental and institutional values, candidates are expected to have the ability to advance the Department’s commitment to diversity and inclusion.

Essential Duties

Job Duty Category Quality System Duty/Responsibility

  • eviews testing, quality control, development study and other reports/data-forms for accuracy, completeness and compliance to requirements to ensure that QA standards and regulatory requirements are met.
  • Participates in internal and external audits and assists departments with the coordination of audit information, and recommends appropriate improvement/mitigation
  • Assists with the monitoring of incidents and CAPAs; supports the mitigation, closure and archiving plans for incidents/CAPAs as well as all other documentation of the organization

Percentage Of Time 50 Job Duty Category Compliance Duty/Responsibility

  • Strives toward a growing knowledge of commonly-used QA concepts, practices, and procedures within cGMP field and is responsible for improving one’s knowledge base of current QA regulations and for informing the Director of any new and/or revised regulations
  • Reviews QA standards, studies existing policies and procedures, and interacts with personnel and clients to evaluate effectiveness of QA program and assists in writing QA policies and procedures

Percentage Of Time 30 Job Duty Category Administrative Duty/Responsibility

  • Assist the organization with change control procedures and events
  • Assists with the monitoring of incidents and CAPAs; supports the mitigation, closure and archiving plans for incidents/CAPAs as well as all other documentation of the organization
  • Keeps the Director informed of the status of the quality system and unusual occurrences.
  • May oversee personnel engaged in QA support activities
  • Perform other assigned duties as necessary

Percentage Of Time 20

Application Details

Special Instructions to Applicants

The job title categories within this pool are for positions (when available) that are within a range of 0.5-1.0 Full Time Equivalent (FTE) effort (i.e., 50-100% work effort); Not to drop below the U.S. Fair Standard Labor Act dollar value thresholds for exempt employees. Hiring into a particular position at a specific FTE effort is based on the availability of task-specific funds, one’s skill set and other variables. Please note that this FTE effort and your salary will be very clearly communicated to you prior to hiring. Continued employment is not guaranteed and is also based on the availability of task-specific funds, one’s skill set and other variables.

  1. Applications will be accepted on a continuous basis. Candidates are likely to be selected prior to the closing date.
  2. This open pool will expire on 02/01/19 and individuals will need to reapply to any new opening to be considered beyond that date.

References will not be contacted without prior notification of candidates.

Conditions of Employment

Pre-employment Criminal Background Check (required for new hires)

Search Contact BioMARCJobs@colostate.edu

EEO Statement

Colorado State University is committed to providing an environment that is free from discrimination and harassment based on race, age, creed, color, religion, national origin or ancestry, sex, gender, disability, veteran status, genetic information, sexual orientation, gender identity or expression, or pregnancy and will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. Colorado State University is an equal opportunity/equal access/affirmative action employer fully committed to achieving a diverse workforce and complies with all Federal and Colorado State laws, regulations, and executive orders regarding non-discrimination and affirmative action. The Office of Equal Opportunity is located in 101 Student Services.

The Title IX Coordinator is the Executive Director of the Office of Support and Safety Assessment, 123 Student Services Building, Fort Collins, CO 80523 -2026, (970) 491-7407.

The Section 504 and ADA Coordinator is the Executive Director of Human Resources and Equal Opportunity, Office of Equal Opportunity, 101 Student Services Building, Fort Collins, CO 80523-0160, (970) 491-5836.

Background Check Policy Statement

Colorado State University (CSU) strives to provide a safe study, work, and living environment for its faculty, staff, volunteers and students. To support this environment and comply with applicable laws and regulations, CSU conducts background checks. The type of background check conducted varies by position and can include, but is not limited to, criminal (felony and misdemeanor) history, sex offender registry, motor vehicle history, financial history, and/or education verification. Background checks will be conducted when required by law or contract and when, in the discretion of the university, it is reasonable and prudent to do so.