Supervisor Production Operations

AVEVA DRUG DELIVERY SYSTEMS INC•Tamarac, FL

1d•Onsite

About The Position

Job Responsibilities: • Uses qualifications to perform process steps whenever necessary to support continuous operations, in accordance with Batch Record manufacturing instructions and current labor standards in order to safely and efficiently manufacture a quality product. • When necessary for continuous operations, assembles, disassembles, and cleans equipment used for manufacturing in accordance with the applicable GMP procedure to ensure proper operation and cleanliness of the equipment. • Performs daily review of batch documentation for accuracy and completeness. At the end of the batch reviews all batch documentation for accuracy and completeness prior to submitting batch for review. • Ensures Operators monitor and document the critical process parameters during the manufacturing process. • Responds to and resolves process & equipment problems independently. Notifies Supervisors and works with other departments (Quality Assurance, Engineering, Technical Services, R&D, etc.) to facilitate resolution of issues. • Works with Quality Assurance and Engineering to ensure the manufacturing process meets quality specifications. • Acts as Subject Matter Expert on production procedures to support investigations, CAPAs, projects, new product introductions, and procedure generation and/or revision. • Monitors production schedules. Troubleshoots scheduling conflicts and coordinates Production resources and with other departments to meet production goals. • Trains new employees for new positions, processes, and retrains others as necessary. • Aids Section Leader in assigning qualified personnel as required to meet weekly production schedule including overtime scheduling as needed. Ensures personnel are properly trained and qualified before assigning tasks. • Complies with and enforces GMP/GDP standards in order to minimize cross contamination, holding personnel directly accountable for compliance. • Ensures housekeeping standards are followed and area is maintained during shift. • Follows all departmental and company safety policies in order to prevent injury to self and others. • Backfills associates in the processing rooms as needed. • Trains and audits production employees to ensure current approved SOP’s are followed. • Supports and promotes all Environmental, Health & Safety initiatives to ensure compliance with corporate and other regulations. • Performs other duties in order to meet department's production schedule or to comply with cGMPs. • Works as a member of the team to achieve all outcomes. • Operates in accordance with our Code of Conduct and Business Ethics, and all established regulatory, compliance and safety requirements. • Performs all work in support of our Values: Collaboration, Courage, Perseverance, and Passion. • Ensures area housekeeping / 5S initiatives are sustained, and all other relevant duties as assigned. • Works as a member of the team to achieve all outcomes. Qualifications Education Batchelor’s Degree in Pharmaceutical Sciences, Engineering or closely allied life sciences discipline. Knowledge, Skills and Abilities Ability to lead by establishing and providing clear goals, direction, motivation, clarity, and support needed for self and others to excel in a continuous improvement culture. Ability to organize and distribute work appropriately in an environment requiring strict adherence to timelines. Demonstrates leadership experience particularly in the areas of approachability, dealing with direct reports, managing diversity, setting goals and objectives and measuring performance. Use the appropriate amount of analysis, experience and judgement to make clear/concise decisions and experience in systematic problem solving. Capacity and tact to address performance of direct reports and provide constructive feedback in a firm and timely manner. Computer literacy with Microsoft office programs and exposure to JDE or other ERPs. Ability to work within a diverse team environment (as part of a team) as demonstrated through previous work experience. Excellent communication skills (written and spoken English) including strong verbal and interpersonal skills to lead and influence. Ability to read English and comprehend documents such as policies, Standard Operating Procedures, batch records and cleaning procedures. Experience 4+ years’ experience in a fast-paced, Lean Manufacturing environment required. Experience in a GMP environment preferred (pharmaceutical manufacturing/ biotechnology). 3+ years experience in aseptic environments, sterile filling, or aseptic technique preferred. 3+ years experience with Blow-Fill-Seal (BFS) manufacturing highly preferred. Must be able to fluently read, write and speak in English.

Requirements

Batchelor’s Degree in Pharmaceutical Sciences, Engineering or closely allied life sciences discipline.
Ability to lead by establishing and providing clear goals, direction, motivation, clarity, and support needed for self and others to excel in a continuous improvement culture.
Ability to organize and distribute work appropriately in an environment requiring strict adherence to timelines.
Demonstrates leadership experience particularly in the areas of approachability, dealing with direct reports, managing diversity, setting goals and objectives and measuring performance.
Use the appropriate amount of analysis, experience and judgement to make clear/concise decisions and experience in systematic problem solving.
Capacity and tact to address performance of direct reports and provide constructive feedback in a firm and timely manner.
Computer literacy with Microsoft office programs and exposure to JDE or other ERPs.
Ability to work within a diverse team environment (as part of a team) as demonstrated through previous work experience.
Excellent communication skills (written and spoken English) including strong verbal and interpersonal skills to lead and influence.
Ability to read English and comprehend documents such as policies, Standard Operating Procedures, batch records and cleaning procedures.
4+ years’ experience in a fast-paced, Lean Manufacturing environment required.
Must be able to fluently read, write and speak in English.

Nice To Haves

Experience in a GMP environment preferred (pharmaceutical manufacturing/ biotechnology).
3+ years experience in aseptic environments, sterile filling, or aseptic technique preferred.
3+ years experience with Blow-Fill-Seal (BFS) manufacturing highly preferred.

Responsibilities

Uses qualifications to perform process steps whenever necessary to support continuous operations, in accordance with Batch Record manufacturing instructions and current labor standards in order to safely and efficiently manufacture a quality product.
When necessary for continuous operations, assembles, disassembles, and cleans equipment used for manufacturing in accordance with the applicable GMP procedure to ensure proper operation and cleanliness of the equipment.
Performs daily review of batch documentation for accuracy and completeness. At the end of the batch reviews all batch documentation for accuracy and completeness prior to submitting batch for review.
Ensures Operators monitor and document the critical process parameters during the manufacturing process.
Responds to and resolves process & equipment problems independently. Notifies Supervisors and works with other departments (Quality Assurance, Engineering, Technical Services, R&D, etc.) to facilitate resolution of issues.
Works with Quality Assurance and Engineering to ensure the manufacturing process meets quality specifications.
Acts as Subject Matter Expert on production procedures to support investigations, CAPAs, projects, new product introductions, and procedure generation and/or revision.
Monitors production schedules. Troubleshoots scheduling conflicts and coordinates Production resources and with other departments to meet production goals.
Trains new employees for new positions, processes, and retrains others as necessary.
Aids Section Leader in assigning qualified personnel as required to meet weekly production schedule including overtime scheduling as needed. Ensures personnel are properly trained and qualified before assigning tasks.
Complies with and enforces GMP/GDP standards in order to minimize cross contamination, holding personnel directly accountable for compliance.
Ensures housekeeping standards are followed and area is maintained during shift.
Follows all departmental and company safety policies in order to prevent injury to self and others.
Backfills associates in the processing rooms as needed.
Trains and audits production employees to ensure current approved SOP’s are followed.
Supports and promotes all Environmental, Health & Safety initiatives to ensure compliance with corporate and other regulations.
Performs other duties in order to meet department's production schedule or to comply with cGMPs.
Works as a member of the team to achieve all outcomes.
Operates in accordance with our Code of Conduct and Business Ethics, and all established regulatory, compliance and safety requirements.
Performs all work in support of our Values: Collaboration, Courage, Perseverance, and Passion.
Ensures area housekeeping / 5S initiatives are sustained, and all other relevant duties as assigned.
Works as a member of the team to achieve all outcomes.