QA Team Leader

Vacancy Number:

Location: Lamar Twp

Location Address:
88 Heckmans Gap Rd, Mill Hall
Pennsylvania, PA 17751
United States

Closing Date: 3/31/2023

Be part of our journey
As a global leader in specialty chemicals, we continue to succeed and strengthen our delivery of innovative, sustainable and high-performance solutions. We are passionate and excited about how we can develop and utilize new technologies to shape and inspire changes within an ever-growing market place.

Our ideal person
As a business, it’s really important to us that we find the best person for the job and that you have the best opportunity to succeed in the role. To help, we have outlined our expectations for the role and what core skills and experiences we require as well as what would make you an ideal fit. In turn, we hope this helps you evaluate if this is the right job for you.

• Responsibility for the day-to-day running of the Quality Assurance team function on site
• To supervise the QA team, including division of labor and ensure resources are in place to deliver appropriate QA support to the site
• To deputize for the QA Manager in their absence
• To manage staff to ensure effective performance, by providing appropriate training, making appraisals, proposing award/recognition

• Provide a cGMP QA service including ICHQ7 validation to the site ensuring compliance to external standards is maintained
• Review of quality documentation
• Support the validation activities required as part of a new or existing project where it has been identified that validation is required
• Maintain appropriate training regimes for new and existing QA staff to meet departmental objectives
• Use day to day planning skills to coordinate the supplier complaint, customer complaint and rejection nonconformities. This requires planning, organizing and prioritization of tasks
• Prepare internal/external audit packs and conduct internal audits as required
• Coordinate with the Purchasing Department and maintain the supplier approvals
• Coordinate with Process Development and Sales for the completion of customer questionnaires
• Collate information from SAP and other site databases to be able to contribute to the departmental reports. This involves the undertaking of small projects from about few weeks to a year and some degree of complexity problem solving and communication with relevant personnel on site
• Maintain document entry to the QA Archive/ QMS system
• Ability to deputize for the QA Manager in their absence
• Coordinate the control of change system and development of reports

• Masters degree preferred in relevant scientific discipline or equivalent experience

• 2 years supervisory experience
• 10 years previous QA experience in a pharmaceutical environment
• Knowledge of cGMP, ICHQ7, Q9, Q10, ISO 9001 and FDA guidelines
• SAP experience preferred; but not required
• Database use and experience

• Must have oral & written proficiency in the English language, internally with all functions on site, externally with suppliers, auditors and customers

• Proficient in MS Office
• Knowledge of electronic QMS systems

• Organized, reliable and competent in organizational skills
• High attention to detail
• Able to work as a team

• Able to walk, sit, or stand for a minimum of 8 hours per day