Manager, Quality Operations - Bioservices
2.
6 Garner, NC Garner, NC Full-time Full-time Estimated:
$86.
8K - $110K a year Estimated:
$86.
8K - $110K a year 7 days ago 7 days ago 7 days ago Masy BioServices/Alcami is hiring a Manager, Quality Operations in Garner, NC.
The Manager, Quality Operations leads and manages the Quality team overseeing Biorepository operations at the Garner, North Carolina location.
Responsibilities include the quality review and approval of documents, data, protocols, qualifications, change controls, deviations, and investigations, complaints, and CAPA activities.
The position requires strong leadership behaviors of the Alcami core competencies and non-negotiables, as well as the functional competencies of this profile.
Essential Functions Develops short and long-range goals and objectives, and ensures year-end results are attained.
Monitors quality of the group and optimizes efficiency of the work environment.
Provides technical support including warehousing, stability storage, documentation, and validation activities.
Provides troubleshooting support as needed.
Performs root-cause analysis with appropriate site personnel and ensure the necessary corrective actions are implemented.
Track and measure effectiveness of corrective actions.
Approves controlled documentation generated for and maintained per corporate and regulatory agency procedures Ensures adherence to department, site and corporate SOPs and other regulatory requirements.
Conducts investigations individually and in conjunction with clients.
Effectively communicates with clients and internal groups.
Participates in Quality audits and Regulatory Inspections as requested.
Responsible for the selection, training and development, coaching/mentoring, engagement, retention and performance management of a high performing team to meet the current and evolving needs of the site.
Education and Experience Bachelor of Science degree required.
5-8 years of related pharmaceutical quality experience in a cGMP environment required.
3
years of supervisory experience required.
Prior CMO or CDMO experience preferred.
Prior experience in method Deviation/CAPA/ Product Complaints required.
Functional Competencies Expert knowledge of cGMP.
Knowledge of Good Documentation Practices.
Knowledge of pharmaceutical quality principles in a cGMP environment 21 CFR Parts 210 & 211, EU Regulations and ICH Guidance.
Knowledge of raw material, in-process and finished product manufacturing process and equipment is the Oral Solid Manufacturing and Package space.
Superior documentation skills and thorough understanding of client management.
Excellent leadership, communication and presentation skills.
Excellent skills in strategic planning, problem solving, root-cause analysis and critical thinking required.
Supervisory Responsibilities Directly manages a team, typically 3-6 direct reports.
Participates in the hiring process of other employees.
Makes hiring decisions of other employees.
Schedules and review the work of other employees.
Ensures relevant curriculum assignment and timely completion of training of employees to meet regulatory requirements.
Coaches, mentors and develops other employees.
Prepares and delivers performance evaluations of other employees.
Makes recommendation of disciplinary actions of other employees.
Job Type:
Full-time
Benefits:
401(k) matching Dental insurance Health insurance Life insurance Paid time off Tuition reimbursement Vision insurance Schedule:
8 hour shift Day shift Monday to Friday Work Location:
In person.
Estimated Salary: $20 to $28 per hour based on qualifications.
6 Garner, NC Garner, NC Full-time Full-time Estimated:
$86.
8K - $110K a year Estimated:
$86.
8K - $110K a year 7 days ago 7 days ago 7 days ago Masy BioServices/Alcami is hiring a Manager, Quality Operations in Garner, NC.
The Manager, Quality Operations leads and manages the Quality team overseeing Biorepository operations at the Garner, North Carolina location.
Responsibilities include the quality review and approval of documents, data, protocols, qualifications, change controls, deviations, and investigations, complaints, and CAPA activities.
The position requires strong leadership behaviors of the Alcami core competencies and non-negotiables, as well as the functional competencies of this profile.
Essential Functions Develops short and long-range goals and objectives, and ensures year-end results are attained.
Monitors quality of the group and optimizes efficiency of the work environment.
Provides technical support including warehousing, stability storage, documentation, and validation activities.
Provides troubleshooting support as needed.
Performs root-cause analysis with appropriate site personnel and ensure the necessary corrective actions are implemented.
Track and measure effectiveness of corrective actions.
Approves controlled documentation generated for and maintained per corporate and regulatory agency procedures Ensures adherence to department, site and corporate SOPs and other regulatory requirements.
Conducts investigations individually and in conjunction with clients.
Effectively communicates with clients and internal groups.
Participates in Quality audits and Regulatory Inspections as requested.
Responsible for the selection, training and development, coaching/mentoring, engagement, retention and performance management of a high performing team to meet the current and evolving needs of the site.
Education and Experience Bachelor of Science degree required.
5-8 years of related pharmaceutical quality experience in a cGMP environment required.
3
years of supervisory experience required.
Prior CMO or CDMO experience preferred.
Prior experience in method Deviation/CAPA/ Product Complaints required.
Functional Competencies Expert knowledge of cGMP.
Knowledge of Good Documentation Practices.
Knowledge of pharmaceutical quality principles in a cGMP environment 21 CFR Parts 210 & 211, EU Regulations and ICH Guidance.
Knowledge of raw material, in-process and finished product manufacturing process and equipment is the Oral Solid Manufacturing and Package space.
Superior documentation skills and thorough understanding of client management.
Excellent leadership, communication and presentation skills.
Excellent skills in strategic planning, problem solving, root-cause analysis and critical thinking required.
Supervisory Responsibilities Directly manages a team, typically 3-6 direct reports.
Participates in the hiring process of other employees.
Makes hiring decisions of other employees.
Schedules and review the work of other employees.
Ensures relevant curriculum assignment and timely completion of training of employees to meet regulatory requirements.
Coaches, mentors and develops other employees.
Prepares and delivers performance evaluations of other employees.
Makes recommendation of disciplinary actions of other employees.
Job Type:
Full-time
Benefits:
401(k) matching Dental insurance Health insurance Life insurance Paid time off Tuition reimbursement Vision insurance Schedule:
8 hour shift Day shift Monday to Friday Work Location:
In person.
Estimated Salary: $20 to $28 per hour based on qualifications.
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