Almac Group · 20 hours ago
Quality Control Manager
Audubon, PA
Full-time
Onsite
Mid, Senior Level
3+ years expAlmac Group is currently seeking a Quality Control Manager for their Audubon, PA location. The Quality Control Manager will oversee the Quality Control staff, ensuring compliance with quality specifications and procedures while managing inspections, training, and development of the team.
BiotechnologyHealth CareManufacturingPharmaceutical
Responsibilities
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
Qualification
Required
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
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)
Benefits
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
Company
Almac Group
Almac Group is a contract development and manufacturing firm offering integrated services to pharmaceutical and biotech companies globally.
5001-10000 employees
H1B Sponsorship
Almac Group has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2024 (1)
2021 (1)
Funding
Current Stage
Late StageTotal Funding
$1MKey Investors
Bill & Melinda Gates Foundation
2019-12-04Grant· $1M
Leadership Team
Alan Armstrong
Chairman and CEO
Gerald Donnelly
Analyst
Recent News
2025-10-20
MarketsandMarkets Research Pvt. Ltd.
2025-08-15
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