Manager Quality Pharma

QA MO ______________________________________________

Manage all aspects of the Quality Assurance Function. Overall responsibility for ensuring that the Quality Assurance group has sufficient processes set up to meet cGMPs & customer requirements for the QA groups.

Essential Duties and Responsibilities:

• Ensure compliance with FDA and GMP regulations.
• Direct compliance of government regulations; advise, instruct and recommend policies to ensure compliance.
• Responsible for overall quality system implementation and management.
• Incoming inspection of purchased containers and closures- which includes sampling, testing and release in MRP system. Includes specification development and troubleshooting container/closure issues on the packaging lines. Includes defect tracking and quality indicator reporting.
• Process audits and online finished product inspection - which includes auditing for cGMPs and online customer specifications.
• Online Plastics inspections- inspection Plastics lines for conformance to specifications. Includes specification development and troubleshooting container issues on the packaging lines. Includes defect tracking and quality indicator reporting
• Additional QA Management documentation regulatory review and approvals for Master Data, Annual Product Reviews, QAF-2.
• New Employee Orientation for cGMPs trainer &/or back up.
• Oversight of cCMP major issues on the production floor including additional calls 24/7.
• Production disposition relative to Non-Conforming Materials.

Supervisory Responsibilities:

Supervisor Quality Assurance employees

Education Requirements:

Bachelor's degree in related field required.

Experience Requirements:

Requires 5+ years leadership and 5+ years quality experience in cGMP or other related industry.

Competencies:

• Ability to implement SPC.
• Knowledge of Plastics manufacturing, drug or food manufacturing.
• Project management skills.
• Ability to establish basic training strategies & guidelines for department, e.g., work instructions, SOPs, checklists.
• Ability to direct implementation of SPC within the plant. Working knowledge of Microsoft Office is required. Technical writing skills preferred.
• Excellent leadership skills. Excellent verbal & written communication skills. Ability to effectively communicate with customers, consumers, suppliers, employees & all levels of management within the company.

Certificates, Licenses, Registrations:

Certification in Quality Assurance preferred. American Society of Quality certification preferred.

Travel:

Position may require less than 10% travel

Work Environment:

Worker exposed to typical office conditions. Exposed to extreme heat and cold with temperatures sufficiently high or low to cause marked bodily discomfort. Exposed to sufficient noise to cause worker to shout in order to be heard above the ambient noise level.

Physical Demands:

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

While performing the duties of this job, the employee is regularly required to talk or hear. The employee frequently is required to stand; walk; use hands to finger, handle or feel; and reach with hands and arms.

QA CORP Micro-biology_________________________________________________

• Overall responsibility for ensuring that the QC Microbiology Lab and the Validation team have sufficient processes in place to meet all necessary regulatory and customer requirements, as well as meet all customer service needs.
• Ensure all microbiological standards are met while providing leadership/direction to the team when needed.
• Proactively manage team to meet microbiology and validation goals while also meeting/exceeding customer expectations.
• Assign microbiological testing specifications for all raw materials and finished goods in accordance with regulatory and customer requirements.
• Oversee microbiology method validations for all formulas. Assist laboratory with program organization and prioritization, with focus on USP and Celsis methods.
• Oversee microbiological out-of-specification investigations of any non-conforming raw materials or finished goods.
• Monitor change controls for effects on the status of any micro-sensitive product or process.
• Assist in trouble-shooting any plant quality issues (all plants) specifically those related to possible microbiological contamination.
• Communicate with all levels of management to ensure quality issues are understood and preventive actions are taken.
• Champion a positive quality culture to help ensure products in the market are pure, safe & effective along with meeting customer specifications.
• Create and maintain the yearly budget for the Microbiology Lab.
• Assist contract packagers with quality issues in order to foster a positive working relationship while ensuring production and distribution of high quality products to our customers.
• Monitor all applicable regulatory publications for changes affecting microbiological testing.
• Update, maintain and strengthen all aspects of training for Microbiologists, Laboratory Technicians, Validation Engineers and designated quality personnel. Ensure all personnel keep current on data entry and generate consistent, accurate daily/monthly reports.
• Monitor and trend plant environmental data. Submit periodic trend reports to the VP of Quality for all corporate locations.
• Ensure quality team maintains compliance and adheres to commitment to safety in the workplace.
• Effectively address customer requests and concerns to maintain/improve customer satisfaction.
• Responsible for effective hiring, training, and development of team members. Champion attendance policy and ensure performance evaluations keep people informed, maintain open communication and provide timely, honest performance feedback with direction.
• Lead Micro Excellence Team initiatives governing all corporate sites.

Supervisory Responsibilities:

Education Requirements:

Bachelor's degree in Microbiology or related field.

Experience Requirements:

A minimum of 12 years in a leadership role in an OTC (over-the-counter) drug or medical device manufacturing facility, with a majority of that experience in a Microbiology Lab environment. Extensive experience in representing multiple FDA regulated drug manufacturing and distribution sites during FDA audits. Experience in representing an OTC company during customer audits including contract customers and 3rd party auditors. A comprehensive knowledge of the FD&C Act and 21 CFR Parts 210/211 & 11 along with industry required standards for pharmaceutical and OTC drugs. Superior communication and leadership skills required.

Competencies:

Project management, technical writing, data analysis, knowledge of Microbiology laboratory testing and practices, and knowledge of current Good Manufacturing Practices are mandatory.

Certificates, Licenses, Registrations:

Travel:

Work Environment:

This job operates in a professional office environment. This role routinely uses standard office equipment such as computers, phones, photocopiers, filing cabinets and fax machines.

Physical Demands:

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

While performing the duties of this job, the employee is regularly required to talk or hear. The employee frequently is required to stand; walk; use hands to finger, handle or feel; and reach with hands and arms.

Manager Quality Microbiology _________________________________________

The Manager Quality, Microbiology willoversee the microbiology department including staff, process workflows, quality, safety, and client communication to ensure the reliability, timeliness, and accuracy of all results. The Manager of Microbiologywill lead and guide all aspects of our Microbiology laboratory staff, resources, equipment, and the lab environment. This position ensures safety is closely adhered to and motivates staff to focus on preventing problems before they happen. The Microbiology Manager strengthens the overall proficiency and depth of talent in the Microbiology laboratory by establishing outstanding performance expectations and ensuring both technical and leadership skills are developed by mentoring staff.

Essential Duties and Responsibilities:

• Overall responsibility for ensuring that the QC Microbiology Lab and the Validation team have sufficient processes in place to meet all necessary regulatory and customer requirements, as well as meet all customer service needs.
• Ensure all microbiological standards are met while providing leadership/direction to the team when needed.
• Proactively manage team to meet microbiology and validation goals while also meeting/exceeding customer expectations.
• Assign microbiological testing specifications for all raw materials and finished goods in accordance with regulatory and customer requirements.
• Oversee microbiology method validations for all formulas. Assist laboratory with program organization and prioritization, with focus on USP and Celsis methods.
• Oversee microbiological out-of-specification investigations of any non-conforming raw materials or finished goods.
• Monitor change controls for effects on the status of any micro-sensitive product or process.
• Assist in trouble-shooting any plant quality issues (all plants) specifically those related to possible microbiological contamination.
• Communicate with all levels of management to ensure quality issues are understood and preventive actions are taken.
• Champion a positive quality culture to help ensure products in the market are pure, safe & effective along with meeting customer specifications.
• Create and maintain the yearly budget for the Microbiology Lab.
• Assist contract packagers with quality issues in order to foster a positive working relationship while ensuring production and distribution of high quality products to our customers.
• Monitor all applicable regulatory publications for changes affecting microbiological testing.
• Update, maintain and strengthen all aspects of training for Microbiologists, Laboratory Technicians, Validation Engineers and designated quality personnel. Ensure all personnel keep current on data entry and generate consistent, accurate daily/monthly reports.
• Monitor and trend plant environmental data. Submit periodic trend reports to the VP of Quality for all corporate locations.
• Ensure quality team maintains compliance and adheres to commitment to safety in the workplace.
• Effectively address customer requests and concerns to maintain/improve customer satisfaction.
• Responsible for effective hiring, training, and development of team members. Champion attendance policy and ensure performance evaluations keep people informed, maintain open communication and provide timely, honest performance feedback with direction.
• Lead Micro Excellence Team initiatives governing all corporate sites.

Supervisory Responsibilities:

Education Requirements:

Bachelor's degree in Microbiology or related field.

Experience Requirements:

A minimum of 12 years in a leadership role in an OTC (over-the-counter) drug or medical device manufacturing facility, with a majority of that experience in a Microbiology Lab environment. Extensive experience in representing multiple FDA regulated drug manufacturing and distribution sites during FDA audits. Experience in representing an OTC company during customer audits including contract customers and 3rd party auditors. A comprehensive knowledge of the FD&C Act and 21 CFR Parts 210/211 & 11 along with industry required standards for pharmaceutical and OTC drugs. Superior communication and leadership skills required.

Competencies:

Project management, technical writing, data analysis, knowledge of Microbiology laboratory testing and practices, and knowledge of current Good Manufacturing Practices are mandatory.

Certificates, Licenses, Registrations:

Travel:

Work Environment:

This job operates in a professional office environment. This role routinely uses standard office equipment such as computers, phones, photocopiers, filing cabinets and fax machines.

Physical Demands:

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

While performing the duties of this job, the employee is regularly required to talk or hear. The employee frequently is required to stand; walk; use hands to finger, handle or feel; and reach with hands and arms.