Quality Control Manager Visa Sponsorship Jobs in Pennsylvania

Location:

Audubon, PA

Job Id: 5539

# of Openings: 1

Almac Group is currently seeking a Quality Control Manager for our Audubon, PA location. The Quality Control Manager will manage the activities of Quality Control staff ensuring continuous receipt and inspection of materials in accordance with quality specifications and procedures. Responsible for training, development, motivating and counseling of quality control staff, estimating personnel needs, assigning work, meeting completion dates, interpreting and ensuring consistent application of organizational policies and client requirements.

Responsibilities include but are not limited to:

• Supervise a team of Quality Control staff responsible for conducting incoming drug product and component inspections, in-process inspections, finished product inspection and assessment of cleaned equipment and production lines by visual and swab analysis.

• Ensure that resources are allocated and activities are scheduled to provide an effective and timely service to support business requirements across multiple shifts.

• Ensure that all inspections, analysis and associated tasks are performed in accordance with quality policies and procedures, satisfy the requirements of cGxP and are in accordance with the appropriate regulatory guidelines.

• Ensure that Quality Management System documents (Deviations, CAPA, Change Control and Suspect Analytical Result Reports) are initiated and resolved.

• Track and monitor key process indicators related to Quality Control and implement programs designed to increase department and company employee awareness and knowledge of product nonconformities.

• Mentor and develop the QC team by establishing and implementing performance measures.

• Provide quality authoring, review and/or approval of GxP records including SOPs, Policies, Guidelines, specifications analytical data packs, environmental monitoring data, calibration records and validation documentation.

• Develop, implement and assess processes and policies designed to test products and services.

• Monitor and evaluate current testing processes and procedures, making recommendations for improvements when necessary.

• Manage the environmental monitoring program for all GxP areas on site including testing, trending and deviation resolution.

• Management of Building Management Systems (BMS) review and trending.

• Environmental Monitoring Sampling review and trending.

• Investigation of BMS alarm notifications.

• Responsible for the Quality Control equipment, Cleaning Validation and Analytical/QC method transfer processes.

• Ensure QC equipment maintenance is appropriate including coordination of instrument calibrations.

• Interface with the Facilities department to ensure proper planned maintenance and calibration activities are completed/maintained for equipment owned by the Quality Control, Quality Assurance and Technical Quality/Validation areas (Analytical equipment, weights, temperature loggers, etc.).

• Oversee Analytical Instrument Qualification (AIQ) and requalification activities of equipment and temperature-controlled units (Laboratory Refrigerators and Freezers).

• Support QC method transfers and Cleaning Validation Activities.

• Ensure adequate supplies of materials, consumables and equipment are available to support projects and that purchase orders are created with appropriate project coding.

• Participate in internal, regulatory and client audits of the Almac Pharma Services facility and operations.

• Participate in and support QC related activities during client and regulatory audits.

• Assist/Perform internal quality and vendor/Supplier audits in either a lead or team auditor role.

• Assist in appropriate problem-solving initiatives to address client or regulatory quality issues.

Qualifications

Required Experience / Education:

• Bachelors’ Degree in science or technical related field
• Minimum 3 years Quality experience in an GxP operational or development setting with demonstrated knowledge of techniques for assessing the quality of processes and the ability to guide others in these activities.
• Support of regulatory audits, internal and/or supplier audits (>2 years)
• Experience in packaging and/or laboratory environments and associated equipment (>2 years)
• Environmental monitoring (air viable/non-viable, surface sampling and micro testing) experience (>2 years)

Preferred Experience / Education:

• Bachelors degree in scientific discipline
• Previous experience as a QC Team Leader, Supervisor or Manager (>2 year)
• Experience with Analytical Instrument Qualification (any)
• Experience with Cleaning Validation for shared primary packaging equipment (any)

What can Almac Group offer you?

• Medical, Vision & Dental benefits from the 1st of the month following start date
• 20 days PTO per year, accrued monthly following start date
• 12 holidays per year as well as one day for Annual Diversity Day
• Company paid Long and Short-term disability along with Life Insurance
• 401k company contribution
• Professional development programs/ continuous learning opportunities

Almac is an exceptional, award winning, drug development solutions provider at the forefront of the pharmaceutical industry. We are a privately owned organization that has organically grown over 50 years now employing over 7,500 highly skilled personnel worldwide. Our US Headquarters is located at Souderton, PA with additional operations scattered around the US and Europe. ‘Partnering to Advance Human Health’ is more than just a tagline – it is our way of life.

Embracing diversity is at the heart of enhancing Almac Group’s unique culture and reflects our fundamental belief that all people deserve equality, inclusivity and the opportunity for advancement. We are committed to cultivating a welcoming, supportive, and inclusive environment for all. Together, we will build on the strength in our diversity and deliver exceptional solutions to advance human health globally.

RECRUITMENT AGENCIES PLEASE NOTE: Almac will only accept applications from agencies/business partners that have been invited to work on this role through our portal. Candidate Resumes/CV’s not submitted through our portal or directly to Hiring Managers will be considered unsolicited and no fee will be payable. Thank you for your cooperation.

Almac Group, Inc. is an Equal Opportunity Employer - Minorities/Women/Protected Veterans/Disabled - Proudly embracing diversity in all of its expressions.

EEO is the Law

EEO is the Law GINA Supplement

Almac provides reasonable accommodations to people with disabilities who need assistance completing the application process. Please email us at ADARequest@almacgroup.com to request assistance.