Address
Form of workJOB PURPOSE
To ensure the Quality and Compliance of operational activities occurring at the facility by overseeing the following programs; validation, internal auditing, data review, product complaints, product lifecyle, change management, investigations, CAPA and continuous improvement.
KNOWLEDGE, EXPERIENCE AND EDUCATION
MAJOR DUTIES
Major Duties / Responsibilities
% of Time
1. Provides support and oversight of site activities related to quality
50%
2. Participates in quality events and closes unplanned deviation events
20%
3. Conducts training for direct reports and takes part in needed training to perform job function.
10%
4. Provides performance based feedback to direct reports, including completion of annual performance reviews.
5%
5. Seeks assistance on Human Resource issues.
5%
6. Participates in Continuous Improvement initiatives.
10%
ORGANIZATION STRUCTURE AND FUNCTIONS
Total Direct Reports: 5-10 QA engineers
PRINCIPAL CHALLENGES
Typical Problems
Communicating with the site regarding compliance activities and ensuring that there is alignment on timelines, requirements and resolution to the issue.
Most Complex Problems
Dealing with major problems with employee performance involving Human Resources, assisting implementation of department policies or multi departmental improvement/compliance initiatives and participating in risk analysis involving complex quality events where risk management tools (FMEA, comparison matrix, etc.) are used to derive risk and recommendations to the site.
Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities
The contractor 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. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor's legal duty to furnish information. 41 CFR 60-1.35(c)
To ensure the Quality and Compliance of operational activities occurring at the facility by overseeing the following programs; validation, internal auditing, data review, product complaints, product lifecyle, change management, investigations, CAPA and continuous improvement.
KNOWLEDGE, EXPERIENCE AND EDUCATION
- Bachelor's Degree in engineering, as scientific discipline or closely aligned field. 5+ years experience in a cGMP manufacturing environment, preferably in a quality discipline and zero to two years of previous supervisory experience preferred
- Demonstrated experience applying cGMP's and US FDA laws and requirements in an FDA regulated industry, preferably pharmaceutical.
- Excellent oral and written communication, interpersonal skills, and computer literacy, including Microsoft Excel and Word.
- Strong attention to detail and ability to follow written procedures. Strong ability to make quality decisions when upset conditions arise.
- Knowledge and experience in validation concepts (process, method, computer and cleaning), equipment qualification, change management, product lifecycle, master record approval, internal auditing, data review, risk mitigation, investigations and CAPA planning.
MAJOR DUTIES
Major Duties / Responsibilities
% of Time
1. Provides support and oversight of site activities related to quality
50%
2. Participates in quality events and closes unplanned deviation events
20%
3. Conducts training for direct reports and takes part in needed training to perform job function.
10%
4. Provides performance based feedback to direct reports, including completion of annual performance reviews.
5%
5. Seeks assistance on Human Resource issues.
5%
6. Participates in Continuous Improvement initiatives.
10%
ORGANIZATION STRUCTURE AND FUNCTIONS
Total Direct Reports: 5-10 QA engineers
PRINCIPAL CHALLENGES
Typical Problems
Communicating with the site regarding compliance activities and ensuring that there is alignment on timelines, requirements and resolution to the issue.
Most Complex Problems
Dealing with major problems with employee performance involving Human Resources, assisting implementation of department policies or multi departmental improvement/compliance initiatives and participating in risk analysis involving complex quality events where risk management tools (FMEA, comparison matrix, etc.) are used to derive risk and recommendations to the site.
Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities
The contractor 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. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor's legal duty to furnish information. 41 CFR 60-1.35(c)
