Supervisor - QA Scheduling

Quality Seymour, Indiana


Description

JOB SUMMARY:

Primarily responsible for oversight of the QA Scheduling group and their responsibilities: scheduling for Quality department, stability program administration, laboratory software systems administration, laboratory stock room administration.

ESSENTIAL DUTIES / RESPONSIBILITIES:

• Implement and maintain a system, whether purchased or developed internally, for scheduling sampling/testing/disposition workload for the entire Quality Department
• Act as liaison between Procurement, Planning, Production, Sales and internal Quality groups to communicate scheduling requirements, changes and/or delays to the appropriate parties.
• Responsible for oversight of the site’s stability program, including software, protocols, samples and chambers.
• Responsible for maintaining on-time testing for stability stops and ensuring priorities are properly balanced between commercial and stability testing requirements.
• Responsible for working with applicable person(s) or group(s) for triage and identification of appropriate actions in the event of a BAS alarm indicating stability chamber failure.
• Responsible for working with Chemistry / Microbiology groups in the timely reporting of potential stability failures to Quality Operations & Quality management; assisting with preparation of any resulting Field Alerts including but not limited to supplying current or historical data and trends.
• Responsible for providing stability data and trends to Quality metrics group, under Compliance, for use in Annual Quality Reviews (AQRs); reviewing master batch document changes, protocols, and reports such as AQRS for assessing impact
• Responsible for oversight, administration and support of the laboratory software systems, including but not limited to Chromeleon (CDS- chromatography data system), SampleManager (LIMS - laboratory information management system), and ScienTek (stability program).
• Responsible for oversight of sample receipt / intake process for commercial and stability samples, including issuance of data sheets or initiation of samples in LIMS and/or stability software.
• Responsible for oversight of laboratory stock room and the purchasing activities to support it.
• Responsible for maintaining current Standard Operating Procedures, training modules or work instructions required for department functions.
• Responsible for maintaining groups’ compliance with assigned training plan(s)
• Assure compliance with US, EU, Japanese, and Chinese cGMPs and other regulations and guidance documents as required.
• Assure compliance with applicable QA agreements between the site and any internal or external customers or suppliers.
• Support and/or assist in external and internal audits and regulatory inspections as needed or required
• Provide support for other Quality Administration and/or Quality Organization tasks or responsibilities as needed or required.

Required Education:

Bachelor's Degree ( Minimum)
Preferred - Bachelor's Degree in Scientific Discipline

QUALIFICATIONS/EXPERIENCE:

  • Minimum 10 years of experience in the pharmaceutical industry with Quality and/or Laboratory background preferred. Less experience may be accepted based on the focus and level of that experience.  Demonstrated knowledge, use, and application of cGMPs is required. 

SPECIFIC SKILLS:

  • Strong leadership, communication and follow-up skills are required.
  • Good interpersonal skills with ability to achieve consensus and cooperation with varying departments and personalities are preferred. Strong communication skills (both oral and written) for internal and external contacts are required.
  • Strong attention to detail is mandatory as the primary responsibilities of this position are technical assessment of the completion, validity and compliance of laboratory data; and the compliance of labeling to the approved label proofs.
  • Strong computer skills are required, with proficiency in the following applications essential: MS Word, MS Excel, and MS Access. Familiarity with SAP, Master Control, Sample Manager, and Chromeleon are beneficial.
  • Strong technical writing and problem solving skills. Experience in reviewing scientific documents / reports to assure compliance is a plus.

 

PHYSICAL REQUIREMENTS / ENVIRONMENT:

  • Work is performed primarily indoors in an office setting. The noise level in the work environment is low to moderate. Limited travel may be required.