Job Information
Croda, Inc QA Manager in Mill Hall, Pennsylvania
QA Manager
Vacancy Number: 4467
Location: Lamar, PA
Location Address: 88 Heckmans Gap Rd, Mill Hall, PA 17751
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 marketplace.
Overall Description: Croda is seeking a QA Manager to have accountability for a team providing the QA service to site and to ensure compliance to cGMP standards and that FDA and ICHQ7 requirements are maintained. This role has accountability for the site validation activities required as part of new or existing project(s) where it has been identified that validation is required. The role has responsibility for generation, maintenance, and submission management of regulatory filings.
DUTIES & RESPONSIBILITIES LEADERSHIP · Accountability for the day-to-day running of the Quality Assurance team function on site. · To manage overall department performance, financial, objective setting, appraisals, training and development, recruitment and disciplinary measures. Direct reports include the QA team and administration level employees. · 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 Head of Quality in their absence. · To manage staff to ensure effective performance, by providing appropriate training, making appraisals, proposing award/recognition.
KEY DUTIES: · Provide a cGMP QA service including ICHQ7 validation to a site ensuring compliance to external standards is maintained. Review and approval of all quality documentation and specifications. · Review and approval of validation activities required as part of a new or existing project where it has been identified that validation is required. · Responsibility for generation, maintenance and submission management of regulatory filings · To review completed batch production and laboratory control records of critical process steps including critical deviations before final quality release of API material. This role has final decision on API batch release. · Approval of all specifications. · To communicate matters of quality to internal and external stakeholders, including senior management, external regulators, customers. · To host regulatory, certification and customer audits for the site. · Maintain appropriate training regimes for new and existing QA staff to meet departmental objectives. · Oversee coordination of supplier complaint, customer complaint and manufacturing nonconformities. This requires planning, organizing and prioritization of tasks. Review of critical deviation · Responsibility for completion of internal/external audit schedule. · Responsibility for supplier approval and qualification · Responsibility for Annual Product Quality Review · Responsibility that there is an effective system for maintaining and calibrating critical equipment · Generation of departmental reports · Responsibility for the control of change system and quality approval on changes which could impact product quality · Responsibility for the site stability program · Ability to deputize for the Head of Quality in their absence
QUALIFICATIONS EDUCATION & TRAINING · Masters degree preferred in relevant scientific discipline or equivalent experience
KNOWLEDGE & EXPERIENCE · 5 years management experience · 10 years previous QA experience in a pharmaceutical environment · Knowledge of cGMP, ICHQ7, Q9, Q10, ISO 9001 and FDA guidelines · IRCA Lead Auditor (or other audit experience) · SAP experience preferred; but not required · Knowledge of employment law
SKILLS & ABILITIES COMMUNICATION SKILLS: · Must have oral & written proficiency in the English language, internally with all functions on site, externally with suppliers, auditors and customers
COMPUTER SKILLS: · Proficient in MS Office · Knowledge of electronic QMS systems
OTHER SKILLS: · Organized, reliable and high attention to detail · Able to work as a team
PHYSICAL DEMANDS · Able to walk, sit, or stand for a minimum of 8 hours per day.
Application Information: Croda recognizes employees as our strength and the diversity they bring to our workforce are directly linked to our ongoing success. We are an equal opportunity employer and place a high value on diversity and inclusion at our company. We do not discriminate on the basis of any protected attribute, including age, race, color, religion, national origin, gender, sexual orientation, gender identity, gender expression, marital or veteran status, pregnancy or disability, or any other basis protected under applicable law. In accordance with applicable law, we make reasonable accommodations for applicants' and employees' religious practices and beliefs, as well as any mental health or physical disability needs. Equal Opportunity Employer/Disability/Veterans. This Organization Participates in E-Verify.
How to apply: Interested and qualified candidates, please click on "Apply Now," then continue to the PA CareerLink® provided link for this company's careers page. You are required to complete Croda's online application process.
